Safety and Immunogenicity of a Group B Streptococcus Vacc... | NCT01193920 | Trialant
NCT01193920
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Aug 22, 2014Estimated
Enrollment
380Actual
Phase
Phase 1Phase 2
Conditions
Streptococcal Infections
Interventions
Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Saline solution
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
saline solution
Countries
South Africa
Protocol Section
Identification Module
NCT ID
NCT01193920
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V98_08
Secondary IDs
ID
Type
Description
Link
MCC Reference n° 20100601
Other Identifier
South African authorities
Brief Title
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Official Title
A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 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
Oct 2010
Primary Completion Date
Dec 2011Actual
Completion Date
Dec 2012Actual
First Submitted Date
Sep 1, 2010
First Submission Date that Met QC Criteria
Sep 1, 2010
First Posted Date
Sep 2, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 17, 2013
Results First Submitted that Met QC Criteria
Apr 3, 2014
Results First Posted Date
May 5, 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
Aug 18, 2014
Last Update Posted Date
Aug 22, 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
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
Detailed Description
Not provided
Conditions Module
Conditions
Streptococcal 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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
380Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg
Experimental
Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
2: Placebo - Sterile saline
Placebo Comparator
Non-Pregnant Women who received two injection of saline solution.
Other: Saline solution
3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg
Experimental
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg
Experimental
Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
5: GBS Trivalent Vaccine - 5/5/5 µg
Experimental
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Biological
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Day 61, one month after the second vaccination
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
Day 61, one month after the second vaccination
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Day of delivery
Antibody GMC in Maternal Subjects at Day of Delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
Day of delivery
Secondary Outcomes
Measure
Description
Time Frame
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)
Exclusion Criteria:
Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, Olugbosi M, Sobanjo-Ter Meulen A, Baker S, Dull PM, Narasimhan V, Slobod K. Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy. Clin Infect Dis. 2017 Nov 13;65(11):1897-1904. doi: 10.1093/cid/cix666.
Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
6: Placebo - Sterile saline
Placebo Comparator
Pregnant Women who received one injection of saline solution.
Other: saline solution
1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg
Saline solution
Other
Subjects received two injection of saline solution.
2: Placebo - Sterile saline
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Biological
Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg
Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Biological
Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg
Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
Biological
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
5: GBS Trivalent Vaccine - 5/5/5 µg
saline solution
Other
Subjects received one injection of saline solution.
6: Placebo - Sterile saline
Day 31, one month after vaccination
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
day 31
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
Day 361, one year after the first vaccination
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
Day 361, one year after the first vaccination
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Day 61
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
From day 1 to one year after delivery
Antibody GMC Per Serotype at Different Time Points in Infants
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Day 4, day 43 and day 91 after birth
Number of Infants Reporting Serious Adverse Events
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
one year after birth
Derived
Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.
Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.
Non-pregnant women received two injections of saline solution
FG002
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
FG003
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
FG004
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
FG005
Pregnant/Placebo
Pregnant women who received one injection of saline solution
FG006
Infants 0.5/0.5/0.5 μg
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
FG007
Infants 2.5/2.5/2.5 μg
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
FG008
Infants 5/5/5 μg
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
FG009
Infants / Placebo
Infants born from women who received saline solution
FG00040 subjects
FG00120 subjects
FG00280 subjects
FG00380 subjects
FG00480 subjects
FG00580 subjects
FG00680 subjects
FG00780 subjects
FG00876 subjects
FG00981 subjects
COMPLETED
FG00037 subjects
FG00120 subjects
FG00274 subjects
FG00376 subjects
FG00474 subjects
FG00576 subjects
FG00674 subjects
FG00776 subjects
FG00871 subjects
FG00974 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0026 subjects
FG0034 subjects
FG0046 subjects
FG0054 subjects
FG0066 subjects
FG0074 subjects
FG0085 subjects
FG0097 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0025 subjects
FG0031 subjects
FG0043 subjects
FG0051 subjects
FG0063 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Unable to classify
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Analysis was done on the all enrolled population.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
BG001
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
BG002
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
BG003
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
BG004
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
BG005
Pregnant/Placebo
Pregnant women who received one injection of saline solution
BG006
Infants 0.5/0.5/0.5 μg
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
BG007
Infants 2.5/2.5/2.5 μg
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
BG008
Infants 5/5/5 μg
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
BG009
Infants / Placebo
Infants born from women who received one injection of saline solution
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00120
BG00280
BG00380
BG00480
BG00580
BG00680
BG00780
BG00876
BG00981
BG010697
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
Non pregnant subjects
Title
Measurements
BG00028.6± 5.0
BG00129.4± 5.1
BG002NA± NApresented elsewhere
BG003
Age, Customized
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG000NA± NApresented elsewhere
BG001NA± NApresented elsewhere
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00040
BG00120
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
South Africa
Title
Measurements
BG00040
BG00120
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
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Full Analysis Set (FAS) - primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61
Posted
Number
95% Confidence Interval
percentage of subjects
Day 61, one month after the second vaccination
ID
Title
Description
OG000
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
OG001
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
Units
Counts
Participants
OG00035
OG00119
Title
Denominators
Categories
Serotype Ia >=1 μg/mL (N=34, 19)
Title
Measurements
OG00091(76 to 98)
OG00137(16 to 62)
Serotype Ia >=2 μg/mL (N=34, 19)
Title
Measurements
OG000
Primary
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
FAS - primary, non-pregnant subjects
Posted
Geometric Mean
95% Confidence Interval
concentrations (μg/mL)
Day 61, one month after the second vaccination
ID
Title
Description
OG000
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
OG001
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
Units
Counts
Participants
OG000
Secondary
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31
Posted
Number
95% Confidence Interval
percentage of subjects
Day 31, one month after vaccination
ID
Title
Description
OG000
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
OG001
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
OG002
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
Primary
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery
Posted
Number
95% Confidence Interval
percentage of subjects
Day of delivery
ID
Title
Description
OG000
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
OG001
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
OG002
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
OG003
Primary
Antibody GMC in Maternal Subjects at Day of Delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
FAS primary, maternal subjects
Posted
Geometric Mean
95% Confidence Interval
Concentration (μg/mL)
Day of delivery
ID
Title
Description
OG000
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
OG001
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
OG002
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
OG003
Pregnant/Placebo
Pregnant women who received one injection of saline solution
Secondary
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
FAS, secondary, maternal subjects, day 31
Posted
Geometric Mean
95% Confidence Interval
concentration (μg/mL)
day 31
ID
Title
Description
OG000
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
OG001
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
OG002
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
OG003
Pregnant/Placebo
Pregnant women who received one injection of saline solution
Secondary
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.
Posted
Number
95% Confidence Interval
percentage of subjects
Day 361, one year after the first vaccination
ID
Title
Description
OG000
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
OG001
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
Units
Counts
Participants
Secondary
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
FAS persistence, non-pregnant subjects
Posted
Geometric Mean
95% Confidence Interval
concentration (μg/mL)
Day 361, one year after the first vaccination
ID
Title
Description
OG000
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
OG001
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
Units
Counts
Participants
OG000
Secondary
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects
Posted
Number
participants
Day 61
ID
Title
Description
OG000
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
OG001
Non Pregnant/Placebo
Non pregnant women received two injections of saline solution
Units
Counts
Participants
OG000
Secondary
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
Safety set, solicited and unsolicited reactogenicity, maternal subjects
Posted
Number
participants
From day 1 to one year after delivery
ID
Title
Description
OG000
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
OG001
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
OG002
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
OG003
Pregnant/Placebo
Pregnant women who received one injection of saline solution
Secondary
Antibody GMC Per Serotype at Different Time Points in Infants
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames
Posted
Geometric Mean
95% Confidence Interval
concentration (μg/mL)
Day 4, day 43 and day 91 after birth
ID
Title
Description
OG000
Infants 0.5/0.5/0.5 μg
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
OG001
Infants 2.5/2.5/2.5 μg
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
OG002
Infants 5/5/5 μg
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
OG003
Infants / Placebo
Secondary
Number of Infants Reporting Serious Adverse Events
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
Posted
Number
Number of subjects
one year after birth
ID
Title
Description
OG000
Infants 0.5/0.5/0.5 μg
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
OG001
Infants 2.5/2.5/2.5 μg
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
OG002
Infants 5/5/5 μg
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
OG003
Infants / Placebo
Infants born from women who received saline solution
Time Frame
Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Description
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
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
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
2
40
40
40
EG001
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
1
20
19
20
EG002
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
27
80
72
80
EG003
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
24
80
67
80
EG004
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
25
80
70
80
EG005
Pregnant/Placebo
Pregnant women who received one injection of saline solution
30
80
71
80
EG006
Infants 0.5/0.5/0.5 μg
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
19
79
44
79
EG007
Infants 2.5/2.5/2.5 μg
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
13
79
49
79
EG008
Infants 5/5/5 μg
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
13
74
48
74
EG009
Infants / Placebo
Infants born from women who received one injection of saline solution
18
78
51
78
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
anemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG0030 affected80 at risk
EG0040 affected80 at risk
EG0050 affected80 at risk
EG0060 affected79 at risk
EG0070 affected79 at risk
EG0082 affected74 at risk
EG0090 affected78 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
Tachycardia foetal
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
cardiac disorder
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
congenital pneumonia
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
strabism
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
constipation
Gastrointestinal disorders
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
diarrhoea
Gastrointestinal disorders
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
vomiting
Gastrointestinal disorders
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
jaundice
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
abscess limb
Infections and infestations
MedDRA
EG0001 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
acute tonsillitis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
bronchiolitis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
bronchopneumonia
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
bullous impetigo
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
chorioamnionitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
dysentery
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
eczema herpeticum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
HIV infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
klebsiella sepsis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
meningitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
postoperative wound infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
postpartum sepsis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
pyelonephritis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
sepsis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
sepsis neonatal
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
streptococcal sepsis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
umbilical sepsis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
upper respiratory tract infection
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
urinary tract infection
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
urinary tract infection bacteria
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
wound sepsis
Infections and infestations
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
burns second degree
Injury, poisoning and procedural complications
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
perineal laceration
Injury, poisoning and procedural complications
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
seroma
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
thermal burn
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
vulvovaginal injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
wound secretion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
failure to thrive
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hypernatraemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
coagulation factor IX level decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0011 affected20 at risk
EG0020 affected80 at risk
EG003
dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0011 affected20 at risk
EG0020 affected80 at risk
EG003
convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
convulsion neonatal
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0001 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
breech presentation
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 at risk
EG003
cephalo-pelvic disproportion
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 at risk
EG003
eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
failed induction of labour
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
false labour
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 at risk
EG003
foetal death
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
foetal distress syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG00210 affected80 at risk
EG003
foetal hypokinesia
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0023 affected80 at risk
EG003
haemorrage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hyperemesis gravidarum
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
labour complication
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
postpartum haemorrage
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 at risk
EG003
pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
premature separation of placenta
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
prolonged labour
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0026 affected80 at risk
EG003
prolonged pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
retained product of conception
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 at risk
EG003
stillbirth
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
umbilical cord prolapse
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hydronephrosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
renal impairment
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
vaginal haemorrage
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
neonathal asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
transient tachypnoea of the newborn
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
erythema toxicum neonatorum
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
labour induction
Surgical and medical procedures
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
subgaleal haematoma
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0004 affected40 at risk
EG0011 affected20 at risk
EG0021 affected80 at risk
EG0030 affected80 at risk
EG0040 affected80 at risk
EG0051 affected80 at risk
EG0060 affected79 at risk
EG0070 affected79 at risk
EG0080 affected74 at risk
EG0090 affected78 at risk
nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00017 affected40 at risk
EG0016 affected20 at risk
EG00216 affected80 at risk
EG003
chills
General disorders
MedDRA
Systematic Assessment
EG00015 affected40 at risk
EG0016 affected20 at risk
EG00216 affected80 at risk
EG003
fatigue
General disorders
MedDRA
Systematic Assessment
EG00029 affected40 at risk
EG00112 affected20 at risk
EG00239 affected80 at risk
EG003
feeling hot
General disorders
MedDRA
Non-systematic Assessment
EG0003 affected40 at risk
EG0011 affected20 at risk
EG0022 affected80 at risk
EG003
injection site induration
General disorders
MedDRA
Systematic Assessment
EG00019 affected40 at risk
EG0014 affected20 at risk
EG0027 affected80 at risk
EG003
injection site erythema
General disorders
MedDRA
Systematic Assessment
EG00012 affected40 at risk
EG0013 affected20 at risk
EG00210 affected80 at risk
EG003
injection site haemorrhage
General disorders
MedDRA
Non-systematic Assessment
EG0007 affected40 at risk
EG0013 affected20 at risk
EG0021 affected80 at risk
EG003
injection site pain
General disorders
MedDRA
Systematic Assessment
EG00039 affected40 at risk
EG00115 affected20 at risk
EG00228 affected80 at risk
EG003
injection site swelling
General disorders
MedDRA
Systematic Assessment
EG00014 affected40 at risk
EG0012 affected20 at risk
EG0022 affected80 at risk
EG003
injection site warmth
General disorders
MedDRA
Systematic Assessment
EG00024 affected40 at risk
EG0019 affected20 at risk
EG00221 affected80 at risk
EG003
malaise
General disorders
MedDRA
Systematic Assessment
EG00014 affected40 at risk
EG0017 affected20 at risk
EG00214 affected80 at risk
EG003
pain
General disorders
MedDRA
EG00010 affected40 at risk
EG0013 affected20 at risk
EG0022 affected80 at risk
EG003
pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0006 affected40 at risk
EG0010 affected20 at risk
EG0025 affected80 at risk
EG003
influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected40 at risk
EG0011 affected20 at risk
EG0028 affected80 at risk
EG003
tonsillitis
General disorders
MedDRA
Non-systematic Assessment
EG0003 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected40 at risk
EG0011 affected20 at risk
EG00226 affected80 at risk
EG003
urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected40 at risk
EG0011 affected20 at risk
EG0022 affected80 at risk
EG003
aspartate aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected40 at risk
EG0012 affected20 at risk
EG0020 affected80 at risk
EG003
arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00023 affected40 at risk
EG0016 affected20 at risk
EG00220 affected80 at risk
EG003
myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00029 affected40 at risk
EG00111 affected20 at risk
EG00220 affected80 at risk
EG003
neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0012 affected20 at risk
EG0020 affected80 at risk
EG003
dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
headache
Nervous system disorders
MedDRA
Systematic Assessment
EG00028 affected40 at risk
EG00115 affected20 at risk
EG00247 affected80 at risk
EG003
vaginal discharge
Reproductive system and breast disorders
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 at risk
EG003
cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected40 at risk
EG0010 affected20 at risk
EG0023 affected80 at risk
EG003
nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected20 at risk
EG0024 affected80 at risk
EG003
hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0003 affected40 at risk
EG0010 affected20 at risk
EG0024 affected80 at risk
EG003
induration
General disorders
MedDRA
Non-systematic Assessment
EG0004 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 at risk
EG003
constipation
Gastrointestinal disorders
MedDRA
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
jaundice
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
fungal skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected40 at risk
EG0011 affected20 at risk
EG0020 affected80 at risk
EG003
gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected40 at risk
EG0010 affected20 at risk
EG0021 affected80 at risk
EG003
oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected40 at risk
EG0010 affected20 at risk
EG0020 affected80 at risk
EG003
Influenza like illness
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected40 at risk
EG0010 affected20 at risk
EG0022 affected80 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
Other disclosure agreement: 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
Ancestor Terms
ID
Term
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077330
Saline Solution
Ancestor Terms
ID
Term
D000077324
Crystalloid Solutions
D007552
Isotonic Solutions
D012996
Solutions
D004364
Pharmaceutical Preparations
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
FG0053 subjects
FG0061 subjects
FG0070 subjects
FG0082 subjects
FG0093 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0073 subjects
FG0082 subjects
FG0094 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
NA
± NA
presented elsewhere
BG004NA± NApresented elsewhere
BG005NA± NApresented elsewhere
BG006NA± NApresented elsewhere
BG007NA± NApresented elsewhere
BG008NA± NApresented elsewhere
BG009NA± NApresented elsewhere
BG01028.8± 5.0
Maternal subjects
Title
Measurements
BG000NA± NApresented elsewhere
BG001NA± NApresented elsewhere
BG00225.3± 5.2
BG00325.3± 5.2
BG00424.2± 4.7
BG00525.7± 5.4
BG006NA± NApresented elsewhere
BG007NA± NApresented elsewhere
BG008NA± NApresented elsewhere
BG009NA± NApresented elsewhere
BG01025.1± 5.1
NA
± NA
presented elsewhere
BG003NA± NApresented elsewhere
BG004NA± NApresented elsewhere
BG005NA± NApresented elsewhere
BG0063.0± 3.3
BG0074.0± 7.8
BG0085.5± 16.9
BG0093.5± 8.8
BG0104.0± 10.3
80
BG00380
BG00480
BG00580
BG00645
BG00738
BG00833
BG00948
BG010544
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG00635
BG00742
BG00843
BG00933
BG010153
80
BG00380
BG00480
BG00580
BG00680
BG00780
BG00876
BG00981
BG010697
91
(76 to 98)
OG00132(13 to 57)
Serotype Ia >=3 μg/mL (N=34, 19)
Title
Measurements
OG00088(73 to 97)
OG00126(9 to 51)
Serotype Ia >=5 μg/mL (N=34, 19)
Title
Measurements
OG00079(62 to 91)
OG00116(3 to 40)
Serotype Ia >=8 μg/mL (N=34, 19)
Title
Measurements
OG00076(59 to 89)
OG00116(3 to 40)
Serotype Ib >=1 μg/mL (N=33, 17)
Title
Measurements
OG00073(54 to 87)
OG00124(7 to 50)
Serotype Ib >=2 μg/mL (N=33, 17)
Title
Measurements
OG00067(48 to 82)
OG00112(1 to 36)
Serotype Ib >=3 μg/mL (N=33, 17)
Title
Measurements
OG00064(45 to 80)
OG0016(0 to 29)
Serotype Ib >=5 μg/mL (N=33, 17)
Title
Measurements
OG00042(25 to 61)
OG0016(0 to 29)
Serotype Ib >=8 μg/mL (N=33, 17)
Title
Measurements
OG00039(23 to 58)
OG0016(0 to 29)
Serotype III >=1 μg/mL
Title
Measurements
OG00089(73 to 97)
OG00137(16 to 62)
Serotype III >=2 μg/mL
Title
Measurements
OG00069(51 to 83)
OG00121(6 to 46)
Serotype III >=3 μg/mL
Title
Measurements
OG00063(45 to 79)
OG00121(6 to 46)
Serotype III >=5 μg/mL
Title
Measurements
OG00051(34 to 69)
OG00111(1 to 33)
Serotype III >=8 μg/mL
Title
Measurements
OG00049(31 to 66)
OG0015(0 to 26)
35
OG00119
Title
Denominators
Categories
Serotype Ia (N=34, 19)
Title
Measurements
OG00040(26 to 62)
OG0010.88(0.49 to 1.59)
Serotype Ib (N=33, 17)
Title
Measurements
OG0005.3(2.94 to 9.56)
OG0010.25(0.12 to 0.55)
Serotype III
Title
Measurements
OG00011(6.43 to 19)
OG0010.61(0.29 to 1.27)
OG003
Pregnant/Placebo
Pregnant women who received one injection of saline solution
Units
Counts
Participants
OG00075
OG00174
OG00269
OG00376
Title
Denominators
Categories
serotype Ia>=1μg/mL (N=75, 74, 69, 75)
Title
Measurements
OG00085(75 to 92)
OG00177(66 to 86)
OG00288(78 to 95)
OG00333(23 to 45)
serotype Ia>=2μg/mL (N=75, 74, 69, 75)
Title
Measurements
OG00079(68 to 87)
OG00177(66 to 86)
OG00281(70 to 90)
OG003
serotype Ia>=3μg/mL (N=75, 74, 69, 75)
Title
Measurements
OG00076(65 to 85)
OG00173(61 to 83)
OG00278(67 to 87)
OG003
serotype Ia>=5μg/mL (N=75, 74, 69, 75)
Title
Measurements
OG00075(63 to 84)
OG00170(59 to 80)
OG00271(59 to 81)
OG003
serotype Ia>=8μg/mL (N=75, 74, 69, 75)
Title
Measurements
OG00071(59 to 81)
OG00170(59 to 80)
OG00271(59 to 81)
OG003
serotype Ib>=1μg/mL (N= 65, 69, 66, 61)
Title
Measurements
OG00065(52 to 76)
OG00168(56 to 79)
OG00262(49 to 74)
OG003
serotype Ib>=2μg/mL (N= 65, 69, 66, 61)
Title
Measurements
OG00060(47 to 72)
OG00154(41 to 66)
OG00250(37 to 63)
OG003
serotype Ib>=3μg/mL (N= 65, 69, 66, 61)
Title
Measurements
OG00054(41 to 66)
OG00148(36 to 60)
OG00244(32 to 57)
OG003
serotype Ib>=5μg/mL (N= 65, 69, 66, 61)
Title
Measurements
OG00048(35 to 60)
OG00143(32 to 56)
OG00236(25 to 49)
OG003
serotype Ib>=8μg/mL (N= 65, 69, 66, 61)
Title
Measurements
OG00043(31 to 56)
OG00139(28 to 52)
OG00230(20 to 43)
OG003
serotype III>=1μg/mL (N= 73, 74, 68, 76)
Title
Measurements
OG00070(58 to 80)
OG00165(53 to 76)
OG00257(45 to 69)
OG003
serotype III>=2μg/mL (N=73, 74, 68, 76)
Title
Measurements
OG00058(45 to 69)
OG00154(42 to 66)
OG00251(39 to 64)
OG003
serotype III>=3μg/mL (N=73, 74, 68, 76)
Title
Measurements
OG00048(36 to 60)
OG00150(38 to 62)
OG00244(32 to 57)
OG003
serotype III>=5μg/mL (N=73, 74, 68, 76)
Title
Measurements
OG00041(30 to 53)
OG00143(32 to 55)
OG00232(22 to 45)
OG003
serotype III>=8μg/mL (N=73, 74, 68, 76)
Title
Measurements
OG00038(27 to 50)
OG00134(23 to 46)
OG00229(19 to 42)
OG003
Pregnant/Placebo
Pregnant women who received one injection of saline solution
Units
Counts
Participants
OG00076
OG00177
OG00273
OG00378
Title
Denominators
Categories
Serotype Ia >= 1 μg/mL (N=76,77, 73, 76)
Title
Measurements
OG00086(76 to 93)
OG00183(73 to 91)
OG00289(80 to 95)
OG00338(27 to 50)
Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76)
Title
Measurements
OG00078(67 to 86)
OG00174(63 to 83)
OG00281(70 to 89)
OG003
Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76)
Title
Measurements
OG00075(64 to 84)
OG00171(60 to 81)
OG00277(65 to 86)
OG003
Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76)
Title
Measurements
OG00072(61 to 82)
OG00169(57 to 79)
OG00275(64 to 85)
OG003
Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76)
Title
Measurements
OG00064(53 to 75)
OG00164(52 to 74)
OG00271(59 to 81)
OG003
Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58)
Title
Measurements
OG00058(45 to 70)
OG00165(53 to 76)
OG00265(53 to 76)
OG003
Serotype Ib >= 2 μg/mL (69, 74, 71, 58)
Title
Measurements
OG00052(40 to 64)
OG00151(39 to 63)
OG00248(36 to 60)
OG003
Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58)
Title
Measurements
OG00043(32 to 56)
OG00149(37 to 61)
OG00242(31 to 55)
OG003
Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58)
Title
Measurements
OG00041(29 to 53)
OG00141(29 to 53)
OG00237(25 to 49)
OG003
Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58)
Title
Measurements
OG00036(25 to 49)
OG00136(26 to 48)
OG00232(22 to 45)
OG003
Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78)
Title
Measurements
OG00069(57 to 79)
OG00166(55 to 77)
OG00264(52 to 75)
OG003
Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78)
Title
Measurements
OG00062(50 to 73)
OG00153(42 to 65)
OG00251(39 to 63)
OG003
Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78)
Title
Measurements
OG00049(37 to 61)
OG00144(33 to 56)
OG00242(31 to 55)
OG003
Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78)
Title
Measurements
OG00039(28 to 51)
OG00149(29 to 52)
OG00236(25 to 48)
OG003
Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78)
Title
Measurements
OG00034(23 to 46)
OG00135(25 to 47)
OG00229(19 to 41)
OG003
Units
Counts
Participants
OG00076
OG00177
OG00273
OG00378
Title
Denominators
Categories
Serotype Ia (N= 76, 77, 73, 76)
Title
Measurements
OG0009.95(6.6 to 15)
OG00114(9.19 to 21)
OG00224(16 to 36)
OG0030.67(0.46 to 0.99)
Serotype Ib (N=69, 74, 71, 58)
Title
Measurements
OG0002.5(1.61 to 3.88)
OG0014.3(2.74 to 6.76)
OG0022.93(1.79 to 4.77)
OG003
Serotype III (N=74, 77, 73, 78)
Title
Measurements
OG0002.63(1.8 to 3.85)
OG0013.66(2.52 to 5.31)
OG0022.83(1.92 to 4.17)
OG003
Units
Counts
Participants
OG00075
OG00174
OG00269
OG00376
Title
Denominators
Categories
serotype Ia (N=75, 74, 69, 75)
Title
Measurements
OG00013(8.27 to 21)
OG00115(9.54 to 25)
OG00226(16 to 43)
OG0030.62(0.41 to 0.93)
serotype Ib (N=65, 69, 66, 61)
Title
Measurements
OG0002.78(1.68 to 4.59)
OG0015.42(3.21 to 9.18)
OG0023.66(2.06 to 6.52)
OG003
serotype III (N=73, 74, 68, 76)
Title
Measurements
OG0003.01(1.96 to 4.62)
OG0014.11(2.68 to 6.31)
OG0022.77(1.75 to 4.37)
OG003
OG00037
OG00120
Title
Denominators
Categories
Serotype Ia >=1μg/mL
Title
Measurements
OG00086(71 to 95)
OG00130(12 to 54)
Serotype Ia >=2μg/mL
Title
Measurements
OG00076(59 to 88)
OG00130(12 to 54)
Serotype Ia >=3μg/mL
Title
Measurements
OG00076(59 to 88)
OG00125(9 to 49)
Serotype Ia >=5μg/mL
Title
Measurements
OG00070(53 to 84)
OG00115(3 to 38)
Serotype Ia >=8μg/mL
Title
Measurements
OG00062(45 to 78)
OG00110(1 to 32)
Serotype Ib >=1μg/mL (N=37, 19)
Title
Measurements
OG00081(65 to 92)
OG00121(6 to 46)
Serotype Ib >=2μg/mL (N=37, 19)
Title
Measurements
OG00065(47 to 80)
OG00116(3 to 40)
Serotype Ib >=3μg/mL (37, 19)
Title
Measurements
OG00062(45 to 78)
OG0015(0 to 26)
Serotype Ib >=5μg/mL (N=37, 19)
Title
Measurements
OG00038(22 to 55)
OG0015(0 to 26)
Serotype Ib >=8μg/mL (N=37, 19)
Title
Measurements
OG00032(18 to 50)
OG0015(0 to 26)
Serotype III >=1μg/mL
Title
Measurements
OG00081(65 to 92)
OG00120(6 to 44)
Serotype III >=2μg/mL
Title
Measurements
OG00070(53 to 84)
OG00115(3 to 38)
Serotype III >=3μg/mL
Title
Measurements
OG00065(47 to 80)
OG00115(3 to 38)
Serotype III >=5μg/mL
Title
Measurements
OG00054(37 to 71)
OG0015(0 to 25)
Serotype III >=8μg/mL
Title
Measurements
OG00041(25 to 58)
OG0015(0 to 25)
37
OG00120
Title
Denominators
Categories
serotype Ia
Title
Measurements
OG00015(9.86 to 22)
OG0010.86(0.51 to 1.45)
serotype Ib (N=37, 19)
Title
Measurements
OG0005.28(3.49 to 7.98)
OG0010.4(0.23 to 0.69)
serotype III
Title
Measurements
OG0007.03(4.5 to 11)
OG0010.3(0.17 to 0.55)
40
OG00120
Title
Denominators
Categories
Solicited adverse events
Title
Measurements
OG00040
OG00119
Unsolicited adverse events
Title
Measurements
OG00030
OG00116
Units
Counts
Participants
OG00080
OG00180
OG00280
OG00380
Title
Denominators
Categories
solicited adverse events (N=80, 80, 79, 80)
Title
Measurements
OG00059
OG00146
OG00259
OG00357
unsolicited adverse events
Title
Measurements
OG00070
OG00159
OG00262
OG003
Infants born from women who received saline solution