Safety and Immunogenicity of a Group B Streptococcus Vacc... | NCT01150123

Name	Class
GlaxoSmithKline	INDUSTRY

Safety and Immunogenicity of a Group B Streptococcus Vacc... | NCT01150123 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5 µg_No Adj	Experimental	Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant	Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_No Adj	Experimental	Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant.	Biological: Group B streptococcus (GBS) vaccine- High dose
5 µg_Alum	Experimental	Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.	Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_Alum	Experimental	Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.	Biological: Group B streptococcus (GBS) vaccine- High dose
5 µg_MF59-H	Experimental	Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59	Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_MF59-H

Name	Type	Description	Arm Group Labels	Other Names
Group B streptococcus (GBS) vaccine- low dose	Biological		5 µg_Alum 5 µg_MF59-F 5 µg_MF59-H 5 µg_No Adj

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1	The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.	Day 1 and Day 61
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61	Serotype-specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.	Day 1 and Day 61
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype	Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.	Day 61/Day 1
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2	The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.	Day 1 and Day 361
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361	Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.	Day 1 and Day 361
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1	Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.	Day 1 to Day 7

Name	Affiliation	Role
Novartis Vaccines	Novartis	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26928074	Derived	Leroux-Roels G, Maes C, Willekens J, De Boever F, de Rooij R, Martell L, Bedell L, Wittke F, Slobod K, Dull P. A randomized, observer-blind Phase Ib study to identify formulations and vaccine schedules of a trivalent Group B Streptococcus vaccine for use in non-pregnant and pregnant women. Vaccine. 2016 Apr 4;34(15):1786-91. doi: 10.1016/j.vaccine.2016.02.044. Epub 2016 Mar 5.

Arm/Group Information

ID	Title	Description
FG000	5 µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
FG001	5 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
FG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
FG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
FG004	5 µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
FG005	5 µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
FG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
FG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
FG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart
FG009	5 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
FG010	5 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
FG011	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
FG012	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
FG013	5 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
FG014	5 µg-2 Inj - MF59_F	Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
FG015	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
FG016	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
FG017	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00040 subjects FG00140 subjects FG00239 subjects FG00340 subjects FG00440 subjects FG00540 subjects FG00639 subjects FG00740 subjects FG00820 subjects FG00940 subjects FG01040 subjects FG01140 subjects FG01240 subjects FG01340 subjects FG01440 subjects FG01540 subjects FG01640 subjects FG01720 subjects
COMPLETED		FG00037 subjects FG00138 subjects FG00235 subjects FG00337 subjects FG004
NOT COMPLETED		FG0003 subjects FG0012 subjects FG0024 subjects FG0033 subjects FG004

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0011 subjects FG0022 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	5μg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
BG001	5μg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1

The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.

Analysis was done on primary Per Protocol Set (PPS) - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 61; and had no major protocol violations as defined prior to analysis.

Posted

Number

percentage of subjects

Day 1 and Day 61

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001

Adverse Events Module

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	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Mitral Valve Incompetence	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Middle Ear Effusion	Ear and labyrinth disorders	MedDRA (Unspecified)	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Posting Director	Novartis Vaccines			RegistryContactVaccinesUS@novartis.com

Condition Browse Module

ID	Term
D020275	Guillain-Barre Syndrome
D004194	Disease

ID	Term
D011129	Polyradiculoneuropathy
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

ID	Term
D014612	Vaccines

ID	Term
D001688	Biological Products
D045424	Complex Mixtures

Title

Denominators

Categories

Title	Measurements
	BG00024.3± 5.5 BG00126.2± 7.2 BG00225.5± 5.0 BG00324.1± 4.6 BG00426.5± 6.2 BG00525.1± 5.3 BG00625.1± 6.3 BG00724.3± 6.0 BG00823.5± 3.2 BG00923.4± 4.1 BG01023.5± 5.7 BG01123.5± 5.2 BG01224.7± 6.1 BG01323.6± 5.0 BG01424.9± 5.9 BG01522.7± 4.0 BG01622.9± 5.8 BG01723.5± 5.3 BG01824.3± 5.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00040 BG00140 BG00239 BG00340 BG00440 BG00540 BG00639 BG00740 BG00820 BG00940 BG01040 BG01140 BG01240 BG01340 BG01440 BG01540 BG01640 BG01720 BG018678
Male	BG0000 BG0010 BG0020 BG0030 BG004

Title

Denominators

Categories

Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17)

Title	Measurements
	OG00038 OG00130 OG00230 OG00329 OG00430 OG00538 OG00635 OG00720 OG00818

Day 61 (Serogroup Ia)

Title	Measurements
	OG00098 OG00197 OG00291 OG003

Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17)

Title	Measurements
	OG00024 OG00112 OG00218 OG003

Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16)

Title	Measurements
	OG00082 OG00195 OG00283 OG003

Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17)

Title	Measurements
	OG00018 OG00113 OG00211 OG003

Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17)

Title	Measurements
	OG00070 OG00181 OG00277 OG003

Primary

Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61

Serotype-specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.

Analysis was done on Primary PPS

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Day 1 and Day 61

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00138 OG00235 OG003

Title

Denominators

Categories

Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17)

Title	Measurements
	OG0000.62(0.36 to 1.08) OG0010.51(0.28 to 0.94) OG0020.38(0.21 to 0.71)

Secondary

Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1

Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.

Analysis was done on Solicited Safety Set - All subjects in the Exposed Set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.

Posted

Number

participants

Day 1 to Day 7

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00140 OG00239 OG003

Title

Denominators

Categories

Any Local

Title	Measurements
	OG00030 OG00132 OG00231 OG003

Primary

Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype

Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.

Analysis was done on Primary PPS.

Posted

Geometric Mean

95% Confidence Interval

Ratios

Day 61/Day 1

ID	Title	Description
OG000	5 µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5 µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5 µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00137 OG00234 OG003

Title

Denominators

Categories

serotype Ia; N=40,33,32,35,33,32,34,35,17

Title	Measurements
	OG00032(19 to 53) OG00128(16 to 50) OG00237(21 to 66)

Primary

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2

The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.

Analysis was done on Co-primary PPS - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 361; and had no major protocol violations as defined prior to analysis

Posted

Number

percentage of subjects

Day 1 and Day 361

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart
OG009	5µg-1 Inj - MF59_H	Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG010	5µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG011	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG012	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG013	5µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG014	5µg-2 Inj - MF59_F	Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG015	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG016	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG017	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00132 OG00232 OG003

Title

Denominators

Categories

Day 1 (Serogroup Ia)

Title	Measurements
	OG00038 OG00128 OG00228 OG003

Primary

Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361

Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.

Analysis was done on Co-Primary PPS

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Day 1 and Day 361

ID	Title	Description
OG000	5 µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5 µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5 µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart
OG009	5 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG010	5 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG011	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG012	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG013	5 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG014	5 µg-2 Inj - MF59_F	Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG015	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG016	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG017	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00137 OG00234 OG003

Title

Denominators

Categories

Day1(Serotype Ia)

Title	Measurements
	OG0000.62(0.36 to 1.07) OG0010.45(0.25 to 0.84) OG0020.36(0.2 to 0.67) OG003

Primary

Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361

GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.

Analysis was done on Co-Primary PPS.

Posted

Geometric Mean

95% Confidence Interval

Ratios

Day 1 and day 361

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart
OG009	5µg-1 Inj - MF59_H	Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG010	5µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG011	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG012	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG013	5µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG014	5µg-2 Inj - MF59_F	Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG015	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG016	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG017	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00039 OG00137 OG00233 OG003

Title

Denominators

Categories

Day361/Day1(Serotype Ia)

Title	Measurements
	OG0009.13(5.74 to 15) OG00110(6.09 to 17) OG0029.89(5.87 to 17) OG003

Secondary

Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2

Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.

Analysis was done on Solicited Safety Set

Posted

Number

participants

Day 1 to Day 7

ID	Title	Description
OG000	5µg-1 Inj - MF59_H	Subjects received single active vaccine injection adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG002	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG004	5µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - MF59_F	Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG006	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG008	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00140 OG00240 OG003

Title

Denominators

Categories

Any Local

Title	Measurements
	OG00033 OG00137 OG00236 OG003

Secondary

Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1

Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.

Analysis was done on unsolicited safety set - All subjects in the Exposed Set who provided information about postvaccination unsolicited AEs.

Posted

Number

participants

Day 1 through Day 721

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00140 OG00239 OG003

Title

Denominators

Categories

Any AEs

Title	Measurements
	OG00032 OG00133 OG00231 OG003

Secondary

Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2

Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.

Analysis was done on Unsolicited Safety Set.

Posted

Number

participants

Day 1 through Day 721

ID	Title	Description
OG000	5µg-1 Inj - MF59_H	Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG002	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG004	5µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG006	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG008	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00040 OG00140 OG00240 OG003

Title

Denominators

Categories

Any AEs

Title	Measurements
	OG00030 OG00134 OG00236 OG003

Secondary

Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1

The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.

Analysis was done on secondary persistence PPS - All the subjects who provided all serum sample results from Baseline (prior to vaccination) through Day 721 within protocol required windows.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Day 1 and Day 721

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00036 OG00132 OG00229 OG003

Title

Denominators

Categories

Day 1 (serotype Ia)

Title	Measurements
	OG0000.63(0.35 to 1.11) OG0010.45(0.25 to 0.83) OG0020.39(0.21 to 0.75) OG003

Secondary

Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2

The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.

Analysis was done on secondary persistence PPS.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Day 1 and Day 721

ID	Title	Description
OG000	5µg-1 Inj - MF59_H	Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG002	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG004	5µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - MF59_F	Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG006	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG008	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00035 OG00134 OG00234 OG003

Title

Denominators

Categories

Day 1 (serotype Ia)

Title	Measurements
	OG0000.47(0.27 to 0.81) OG0010.48(0.27 to 0.83) OG0020.28(0.16 to 0.49) OG003

Secondary

Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1

GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.

Analysis was done on secondary persistence PPS

Posted

Geometric Mean

95% Confidence Interval

Ratios

Day 1 and Day 721

ID	Title	Description
OG000	5µg-1 Inj - No Adj	Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
OG002	20 µg-1 Inj - No Adj	Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - No Adj	Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
OG004	5µg-1 Inj - Alum	Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - Alum	Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
OG006	20 µg-1 Inj - Alum	Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- Alum	Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
OG008	Placebo - Group 1	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00036 OG00132 OG00229 OG003

Title

Denominators

Categories

Day 721/Day 1(Serotype Ia)

Title	Measurements
	OG0007.5(4.51 to 12) OG0017.67(4.47 to 13) OG0027.89(4.48 to 14) OG003

Secondary

Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2

GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.

Analysis was done on secondary persistence PPS.

Posted

Geometric Mean

95% Confidence Interval

Ratios

Day 1 and Day 721

ID	Title	Description
OG000	5µg-1 Inj - MF59_H	Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG001	5µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG002	20 µg-1 Inj - MF59_H	Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
OG003	20 µg-2 Inj - MF59_H	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
OG004	5µg-1 Inj - MF59_F	Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG005	5µg-2 Inj - MF59_F	Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG006	20 µg-1 Inj - MF59_F	Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
OG007	20 µg-2 Inj- MF59_F	Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
OG008	Placebo - Group 2	Subjects received two injections of placebo administered 1 month apart

Units	Counts
Participants	OG00035 OG00134 OG00234 OG003

Title

Denominators

Categories

Day 721/Day 1 (Serotype Ia)

Title	Measurements
	OG0003.98(2.55 to 6.2) OG0014.14(2.64 to 6.5) OG0026.12(3.9 to 9.6)

Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17)

Title	Measurements
	OG00020(9.42 to 41) OG00111(5.41 to 24) OG00215(7.08 to 34) OG00318(8.34 to 37) OG00414(6.54 to 30) OG0059.99(4.67 to 21) OG0069.64(4.55 to 20) OG0076.49(3.03 to 14) OG0080.25(0.083 to 0.78)

Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 )

Title	Measurements
	OG0000.15(0.089 to 0.25) OG0010.11(0.065 to 0.19) OG0020.11(0.064 to 0.19) OG0030.11(0.062 to 0.18) OG0040.15(0.088 to 0.26) OG0050.12(0.068 to 0.21) OG0060.12(0.072 to 0.21) OG0070.081(0.046 to 0.14) OG0080.16(0.072 to 0.34)

Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16)

Title	Measurements
	OG0006.75(3.21 to 14) OG0014.56(2.15 to 9.69) OG0024.26(1.95 to 9.34) OG0034.45(2.09 to 9.44) OG0044.72(2.2 to 10) OG0053.85(1.79 to 8.24) OG0063.92(1.85 to 8.32) OG0072.06(0.95 to 4.46) OG0080.24(0.075 to 0.76)

Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17)

Title	Measurements
	OG0000.13(0.08 to 0.2) OG0010.089(0.056 to 0.14) OG0020.087(0.054 to 0.14) OG0030.077(0.049 to 0.12) OG0040.099(0.062 to 0.16) OG0050.15(0.096 to 0.25) OG0060.09(0.057 to 0.14) OG0070.12(0.074 to 0.19) OG0080.1(0.05 to 0.2)

Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17)

Title	Measurements
	OG0003.27(1.6 to 6.68) OG0013.23(1.54 to 6.78) OG0022.31(1.08 to 4.95) OG0032.35(1.13 to 4.89) OG0041.49(0.7 to 3.15) OG0054.3(2.05 to 9.04) OG0061.4(0.67 to 2.94) OG0073.28(1.56 to 6.89) OG0080.1(0.035 to 0.31)

Serotype Ib; N=37,33,33,35,34,32,34,31,16

Title	Measurements
	OG00047(29 to 77) OG00146(27 to 78) OG00239(23 to 66) OG00347(28 to 79) OG00438(22 to 63) OG00532(19 to 54) OG00633(20 to 55) OG00723(13 to 39) OG0081.55(0.73 to 3.28)

Day361(Serotype Ia)

Title

Measurements

OG0005.86(2.93 to 12)
OG0013.78(1.85 to 7.72)
OG0024(1.9 to 8.41)
OG0034.6(2.25 to 9.38)
OG0045.83(2.86 to 12)
OG0055.22(2.56 to 11)
OG0063.78(1.87 to 7.65)
OG0072.94(1.43 to 6.05)
OG0080.26(0.08 to 0.81)
OG0093.62(1.84 to 7.13)
OG0103.04(1.56 to 5.93)
OG0112.13(1.09 to 4.15)
OG0127.19(3.72 to 14)
OG0132.65(1.37 to 5.12)
OG0147.32(3.72 to 14)
OG0152.67(1.36 to 5.24)
OG0164.41(2.28 to 8.52)
OG0170.31(0.12 to 0.77)

Day1(Serotype Ib)

Title

Measurements

OG0000.15(0.089 to 0.25)
OG0010.12(0.066 to 0.2)
OG0020.099(0.058 to 0.17)
OG0030.11(0.062 to 0.18)
OG0040.15(0.085 to 0.25)
OG0050.12(0.069 to 0.2)
OG0060.12(0.073 to 0.21)
OG0070.079(0.046 to 0.14)
OG0080.16(0.073 to 0.33)
OG0090.12(0.071 to 0.21)
OG0100.1(0.058 to 0.17)
OG0110.07(0.04 to 0.12)
OG0120.11(0.062 to 0.18)
OG0130.15(0.083 to 0.26)
OG0140.11(0.065 to 0.2)
OG0150.077(0.044 to 0.13)
OG0160.09(0.053 to 0.15)
OG0170.1(0.048 to 0.22)

Day361(Serotype Ib)

Title

Measurements

OG0004.03(2.38 to 6.83)
OG0013.7(2.15 to 6.36)
OG0022.86(1.62 to 5.03)
OG0033.82(2.22 to 6.58)
OG0043.13(1.82 to 5.38)
OG0054.59(2.67 to 7.89)
OG0063.38(1.98 to 5.77)
OG0072.45(1.41 to 4.24)
OG0080.81(0.33 to 2.03)
OG0092.67(1.53 to 4.66)
OG0103.81(2.19 to 6.61)
OG0111.88(1.08 to 3.27)
OG0125.53(3.21 to 9.54)
OG0133.18(1.85 to 5.48)
OG0145.19(2.97 to 9.08)
OG0153.9(2.23 to 6.82)
OG0163.64(2.11 to 6.27)
OG0170.18(0.079 to 0.39)

Day1(serotype III)

Title

Measurements

OG0000.13(0.08 to 0.2)
OG0010.091(0.057 to 0.15)
OG0020.089(0.055 to 0.15)
OG0030.077(0.049 to 0.12)
OG0040.1(0.064 to 0.16)
OG0050.16(0.1 to 0.26)
OG0060.09(0.057 to 0.14)
OG0070.12(0.074 to 0.19)
OG0080.1(0.05 to 0.2)
OG0090.1(0.066 to 0.17)
OG0100.079(0.05 to 0.13)
OG0110.058(0.037 to 0.092)
OG0120.067(0.042 to 0.11)
OG0130.1(0.066 to 0.16)
OG0140.11(0.067 to 0.17)
OG0150.078(0.049 to 0.12)
OG0160.093(0.059 to 0.15)
OG0170.068(0.036 to 0.13)

Day361(Serotype III)

Title

Measurements

OG0003.05(1.78 to 5.2)
OG0012.71(1.57 to 4.69)
OG0022.45(1.38 to 4.34)
OG0032.78(1.61 to 4.81)
OG0041.77(1.02 to 3.07)
OG0054.48(2.59 to 7.76)
OG0061.77(1.03 to 3.03)
OG0073.46(1.98 to 6.04)
OG0080.13(0.054 to 0.3)
OG0092.33(1.42 to 3.8)
OG0102.67(1.64 to 4.34)
OG0112.06(1.27 to 3.34)
OG0124.5(2.78 to 7.26)
OG0132.62(1.62 to 4.23)
OG0144.99(3.05 to 8.17)
OG0153.07(1.87 to 5.02)
OG0163.51(2.17 to 5.67)
OG0170.076(0.038 to 0.15)

Day361/Day1(Serotype Ib)

Title	Measurements
	OG00028(19 to 40) OG00137(26 to 55) OG00226(18 to 38) OG00338(26 to 55) OG00423(16 to 34) OG00538(26 to 55) OG00627(19 to 39) OG00730(21 to 44) OG0083.97(2.19 to 7.19) OG00923(16 to 33) OG01037(26 to 53) OG01127(18 to 39) OG01254(38 to 76) OG01326(18 to 37) OG01445(31 to 66) OG01549(34 to 71) OG01635(25 to 50) OG0171.75(1.04 to 2.94)

Day361/Day1(Serotype III)

Title	Measurements
	OG00024(16 to 35) OG00130(20 to 45) OG00227(17 to 41) OG00335(23 to 53) OG00417(12 to 26) OG00530(20 to 45) OG00620(13 to 29) OG00731(20 to 47) OG0081.4(0.72 to 2.72) OG00922(15 to 33) OG01035(23 to 53) OG01135(24 to 53) OG01265(44 to 97) OG01326(18 to 40) OG01445(30 to 68) OG01538(26 to 58) OG01638(26 to 56) OG0171.24(0.7 to 2.21)

Day 721 (Serotype Ia)

Title	Measurements
	OG0004.69(2.23 to 9.89) OG0013.48(1.58 to 7.67) OG0023.11(1.36 to 7.14) OG0033.18(1.42 to 7.09) OG0045.1(2.23 to 12) OG0053.01(1.27 to 7.11) OG0063.69(1.69 to 8.03) OG0072.17(0.97 to 4.85) OG0080.3(0.068 to 1.34)

Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6)

Title	Measurements
	OG0000.16(0.089 to 0.28) OG0010.11(0.061 to 0.2) OG0020.094(0.051 to 0.17) OG0030.11(0.063 to 0.2) OG0040.18(0.1 to 0.33) OG0050.13(0.069 to 0.23) OG0060.14(0.078 to 0.27) OG0070.085(0.045 to 0.16) OG0080.88(0.23 to 3.29)

Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6)

Title	Measurements
	OG0002.92(1.51 to 5.64) OG0012.81(1.42 to 5.55) OG0021.71(0.85 to 3.46) OG0032.64(1.37 to 5.1) OG0042.32(1.16 to 4.64) OG0052.96(1.47 to 5.99) OG0062.55(1.26 to 5.15) OG0071.45(0.71 to 2.97) OG0081.02(0.22 to 4.68)

Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6)

Title	Measurements
	OG0000.14(0.083 to 0.23) OG0010.097(0.058 to 0.16) OG0020.094(0.053 to 0.17) OG0030.079(0.047 to 0.13) OG0040.12(0.069 to 0.21) OG0050.16(0.095 to 0.28) OG0060.095(0.057 to 0.16) OG0070.12(0.07 to 0.21) OG0080.071(0.021 to 0.24)

Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6)

Title	Measurements
	OG0003.19(1.77 to 5.77) OG0011.89(1.04 to 3.45) OG0021.7(0.89 to 3.27) OG0032.16(1.2 to 3.91) OG0041.26(0.67 to 2.36) OG0053.87(2.06 to 7.26) OG0061.44(0.8 to 2.6) OG0072.68(1.44 to 4.99) OG0080.054(0.013 to 0.22)

Day 721 (Serotype Ia)

Title	Measurements
	OG0001.86(0.9 to 3.83) OG0011.97(0.95 to 4.11) OG0021.73(0.83 to 3.6) OG0033.09(1.49 to 6.44) OG0041.66(0.82 to 3.39) OG0055.06(2.4 to 11) OG0061.72(0.85 to 3.47) OG0073.32(1.63 to 6.77) OG0080.33(0.12 to 0.9)

Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9)

Title	Measurements
	OG0000.13(0.074 to 0.23) OG0010.092(0.051 to 0.17) OG0020.072(0.04 to 0.13) OG0030.1(0.058 to 0.19) OG0040.15(0.08 to 0.27) OG0050.15(0.077 to 0.28) OG0060.08(0.045 to 0.14) OG0070.094(0.054 to 0.16) OG0080.16(0.055 to 0.46)

Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9)

Title	Measurements
	OG0001.7(0.9 to 3.22) OG0011.72(0.87 to 3.41) OG0021.16(0.59 to 2.27) OG0032.99(1.53 to 5.86) OG0042.5(1.26 to 4.96) OG0054.23(2.02 to 8.84) OG0062.47(1.28 to 4.79) OG0071.93(1.03 to 3.61) OG0080.21(0.063 to 0.7)

Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14)

Title	Measurements
	OG0000.11(0.068 to 0.18) OG0010.082(0.049 to 0.14) OG0020.061(0.037 to 0.1) OG0030.071(0.043 to 0.12) OG0040.09(0.054 to 0.15) OG0050.12(0.069 to 0.2) OG0060.077(0.048 to 0.12) OG0070.1(0.06 to 0.17) OG0080.061(0.028 to 0.13)

Day721(Serotype III;N=34,32,34,32,33,31,36,33,14)

Title	Measurements
	OG0001.72(1 to 2.96) OG0011.59(0.91 to 2.79) OG0021.29(0.75 to 2.23) OG0032.48(1.42 to 4.33) OG0042.04(1.17 to 3.53) OG0053.18(1.8 to 5.61) OG0061.78(1.05 to 3.02) OG0072.05(1.18 to 3.56) OG0080.075(0.032 to 0.17)

Day 721/ Day 1 (Serotype Ib)

Title	Measurements
	OG00019(12 to 28) OG00126(17 to 40) OG00218(12 to 29) OG00324(15 to 36) OG00413(8.16 to 20) OG00523(15 to 37) OG00618(11 to 28) OG00717(11 to 27) OG0081.17(0.44 to 3.1)

Day 721/ Day 1 (Serotype III)

Title	Measurements
	OG00023(15 to 35) OG00119(13 to 30) OG00218(11 to 29) OG00327(18 to 41) OG00411(6.81 to 16) OG00524(15 to 37) OG00615(10 to 23) OG00722(14 to 35) OG0080.76(0.28 to 2.06)

Day 721/Day 1 (Serotype Ib)

Title	Measurements
	OG00013(8.76 to 20) OG00119(12 to 29) OG00216(10 to 24) OG00329(19 to 44) OG00417(11 to 26) OG00529(18 to 45) OG00631(20 to 47) OG00720(14 to 30) OG0081.31(0.61 to 2.8)

Day 721/Day 1 (Serotype III)

Title	Measurements
	OG00016(10 to 24) OG00119(12 to 30) OG00221(14 to 33) OG00335(22 to 54) OG00423(15 to 35) OG00527(17 to 43) OG00623(15 to 35) OG00721(13 to 32) OG0081.22(0.62 to 2.4)