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CompletedNCT01150123Updated May 15, 2017Results posted

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

A Phase 1 interventional study of Group B streptococcus (GBS) vaccine- low dose and Group B streptococcus (GBS) vaccine- High dose in Group B Streptococcus, sponsored by Novartis Vaccines. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-15.

Sponsored by Novartis Vaccines · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
678
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.

02

Conditions studied

  • Group B Streptococcus

Keywords

  • Group B streptococcus
  • GBS
  • Vaccine
  • Group B streptococcus (GBS) disease
03

In context

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy females 18-40 years of age inclusive.

Exclusion criteria

Exclusion Criteria:

  • Individuals who are pregnant or nursing.
  • Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion.
  • Individuals with a history of severe allergic reactions after previous vaccination
  • Individuals with designated blood tests that are not within normal range
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
678 participants (actual)

Study arms

  • Experimental
    5 µg_No Adj

    Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant

    Biological: Group B streptococcus (GBS) vaccine- low dose

  • Experimental
    20 µg_No Adj

    Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant.

    Biological: Group B streptococcus (GBS) vaccine- High dose

  • Experimental
    5 µg_Alum

    Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.

    Biological: Group B streptococcus (GBS) vaccine- low dose

  • Experimental
    20 µg_Alum

    Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.

    Biological: Group B streptococcus (GBS) vaccine- High dose

  • Experimental
    5 µg_MF59-H

    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

  • Experimental
    20 µg_MF59-H

    Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59

    Biological: Group B streptococcus (GBS) vaccine- High dose

  • Experimental
    5 µg_MF59-F

    Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59

    Biological: Group B streptococcus (GBS) vaccine- low dose

  • Experimental
    20 µg_MF59-F

    Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59

    Biological: Group B streptococcus (GBS) vaccine- High dose

  • Placebo comparator
    Placebo

    Subjects received 2 injections of placebo administered 1 month apart

    Biological: Placebo- Saline

Interventions

  • BiologicalGroup B streptococcus (GBS) vaccine- low dose
  • BiologicalGroup B streptococcus (GBS) vaccine- High dose
  • BiologicalPlacebo- Saline
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 and Day 61

  2. 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.

    Time frame: Day 1 and Day 61

  3. 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.

    Time frame: Day 61/Day 1

  4. 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.

    Time frame: Day 1 and Day 361

  5. 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.

    Time frame: Day 1 and Day 361

  6. 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.

    Time frame: Day 1 and day 361

Secondary outcomes

  1. 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.

    Time frame: Day 1 to Day 7

  2. 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.

    Time frame: Day 1 to Day 7

  3. 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.

    Time frame: Day 1 through Day 721

  4. 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.

    Time frame: Day 1 through Day 721

  5. 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.

    Time frame: Day 1 and Day 721

  6. 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.

    Time frame: Day 1 and Day 721

  7. 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.

    Time frame: Day 1 and Day 721

  8. 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.

    Time frame: Day 1 and Day 721

07

Results

Posted May 15, 2017

Participant flow

Subjects were enrolled at one center in Belgium

Participant flow — Overall Study
Milestone5 µg-1 Inj - No Adj5 µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5 µg-1 Inj - Alum5 µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 15 µg-1 Inj - MF59_H5 µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5 µg-1 Inj - MF59_F5 µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Started404039404040394020404040404040404020
Completed373835373734393715393839374040394019
Not completed324336035121300101
Withdrew: Withdrawal by subject112111032010100101
Withdrew: Lost to follow-up212225003111200000

Outcome measures

PrimaryPercentage 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.

Time frame:
Day 1 and Day 61
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
percentage of subjects5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 1
Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17)383030293038352018
Day 61 (Serogroup Ia)989791959795878418
Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17)24121817261624918
Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16)829583847886846419
Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17)181311131628161812
Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17)708177796786707612
PrimaryGeometric 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.

Time frame:
Day 1 and Day 61
Reported as:
Geometric mean · µg/mL
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
µg/mL5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 1
Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17)0.62 (0.36 to 1.08)0.51 (0.28 to 0.94)0.38 (0.21 to 0.71)0.45 (0.25 to 0.81)0.48 (0.26 to 0.87)0.57 (0.31 to 1.06)0.54 (0.29 to 0.98)0.37 (0.2 to 0.67)0.25 (0.11 to 0.59)
Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17)20 (9.42 to 41)11 (5.41 to 24)15 (7.08 to 34)18 (8.34 to 37)14 (6.54 to 30)9.99 (4.67 to 21)9.64 (4.55 to 20)6.49 (3.03 to 14)0.25 (0.083 to 0.78)
Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 )0.15 (0.089 to 0.25)0.11 (0.065 to 0.19)0.11 (0.064 to 0.19)0.11 (0.062 to 0.18)0.15 (0.088 to 0.26)0.12 (0.068 to 0.21)0.12 (0.072 to 0.21)0.081 (0.046 to 0.14)0.16 (0.072 to 0.34)
Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16)6.75 (3.21 to 14)4.56 (2.15 to 9.69)4.26 (1.95 to 9.34)4.45 (2.09 to 9.44)4.72 (2.2 to 10)3.85 (1.79 to 8.24)3.92 (1.85 to 8.32)2.06 (0.95 to 4.46)0.24 (0.075 to 0.76)
Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17)0.13 (0.08 to 0.2)0.089 (0.056 to 0.14)0.087 (0.054 to 0.14)0.077 (0.049 to 0.12)0.099 (0.062 to 0.16)0.15 (0.096 to 0.25)0.09 (0.057 to 0.14)0.12 (0.074 to 0.19)0.1 (0.05 to 0.2)
Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17)3.27 (1.6 to 6.68)3.23 (1.54 to 6.78)2.31 (1.08 to 4.95)2.35 (1.13 to 4.89)1.49 (0.7 to 3.15)4.3 (2.05 to 9.04)1.4 (0.67 to 2.94)3.28 (1.56 to 6.89)0.1 (0.035 to 0.31)
SecondaryNumber 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.

Time frame:
Day 1 to Day 7
Reported as:
Number · participants
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
participants5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 1
Any Local30323135393738398
Inj site Induration91369121616153
Inj site swelling5555781682
Ecchymosis537254020
Redness889891215143
Warmth1011913111411161
Inj site Pain28283134393738397
Any Systemic252122282720292111
Chills325231443
Nausea658576541
Malaise761111791292
Myalgia617835862
Arthralgia213233360
Headache16151318191719117
Fatigue1891821191317136
Rash100111000
Fever (≥ 38C)201112030
PrimaryGeometric 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.

Time frame:
Day 61/Day 1
Reported as:
Geometric mean · Ratios
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
Ratios5 µg-1 Inj - No Adj5 µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5 µg-1 Inj - Alum5 µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 1
serotype Ia; N=40,33,32,35,33,32,34,35,1732 (19 to 53)28 (16 to 50)37 (21 to 66)45 (26 to 78)36 (20 to 64)23 (13 to 42)25 (14 to 44)19 (11 to 33)1.01 (0.46 to 2.24)
Serotype Ib; N=37,33,33,35,34,32,34,31,1647 (29 to 77)46 (27 to 78)39 (23 to 66)47 (28 to 79)38 (22 to 63)32 (19 to 54)33 (20 to 55)23 (13 to 39)1.55 (0.73 to 3.28)
Serotype III26 (16 to 43)36 (22 to 61)26 (15 to 45)30 (18 to 50)15 (8.71 to 25)30 (18 to 50)16 (9.48 to 26)30 (18 to 50)1.13 (0.52 to 2.46)
PrimaryPercentage 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.

Time frame:
Day 1 and Day 361
Reported as:
Number · percentage of subjects
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
percentage of subjects5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 15µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Day 1 (Serogroup Ia)382828293539352218302916282938213120
Day 361 (Serogroup Ia)857888868692797514788276956992769020
Day 1 (Serogroup Ib)241315172615249182415626231961124
Day 361 (Serogroup Ib)95929197921001008946921008797959710010022
Day 1 (Serogroup III)18141213163016181214115814141180
Day 361 (Serogroup III)8584829576958789208695921008710089926
PrimaryGeometric 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.

Time frame:
Day 1 and Day 361
Reported as:
Geometric mean · µg/mL
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
µg/mL5 µg-1 Inj - No Adj5 µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5 µg-1 Inj - Alum5 µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 15 µg-1 Inj - MF59_H5 µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5 µg-1 Inj - MF59_F5 µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Day1(Serotype Ia)0.62 (0.36 to 1.07)0.45 (0.25 to 0.84)0.36 (0.2 to 0.67)0.45 (0.25 to 0.8)0.53 (0.29 to 0.96)0.62 (0.34 to 1.14)0.54 (0.3 to 0.97)0.37 (0.21 to 0.66)0.25 (0.11 to 0.58)0.54 (0.32 to 0.91)0.43 (0.25 to 0.72)0.27 (0.16 to 0.45)0.36 (0.22 to 0.61)0.44 (0.26 to 0.73)0.46 (0.27 to 0.79)0.36 (0.21 to 0.6)0.45 (0.27 to 0.75)0.34 (0.17 to 0.7)
Day361(Serotype Ia)5.86 (2.93 to 12)3.78 (1.85 to 7.72)4 (1.9 to 8.41)4.6 (2.25 to 9.38)5.83 (2.86 to 12)5.22 (2.56 to 11)3.78 (1.87 to 7.65)2.94 (1.43 to 6.05)0.26 (0.08 to 0.81)3.62 (1.84 to 7.13)3.04 (1.56 to 5.93)2.13 (1.09 to 4.15)7.19 (3.72 to 14)2.65 (1.37 to 5.12)7.32 (3.72 to 14)2.67 (1.36 to 5.24)4.41 (2.28 to 8.52)0.31 (0.12 to 0.77)
Day1(Serotype Ib)0.15 (0.089 to 0.25)0.12 (0.066 to 0.2)0.099 (0.058 to 0.17)0.11 (0.062 to 0.18)0.15 (0.085 to 0.25)0.12 (0.069 to 0.2)0.12 (0.073 to 0.21)0.079 (0.046 to 0.14)0.16 (0.073 to 0.33)0.12 (0.071 to 0.21)0.1 (0.058 to 0.17)0.07 (0.04 to 0.12)0.11 (0.062 to 0.18)0.15 (0.083 to 0.26)0.11 (0.065 to 0.2)0.077 (0.044 to 0.13)0.09 (0.053 to 0.15)0.1 (0.048 to 0.22)
Day361(Serotype Ib)4.03 (2.38 to 6.83)3.7 (2.15 to 6.36)2.86 (1.62 to 5.03)3.82 (2.22 to 6.58)3.13 (1.82 to 5.38)4.59 (2.67 to 7.89)3.38 (1.98 to 5.77)2.45 (1.41 to 4.24)0.81 (0.33 to 2.03)2.67 (1.53 to 4.66)3.81 (2.19 to 6.61)1.88 (1.08 to 3.27)5.53 (3.21 to 9.54)3.18 (1.85 to 5.48)5.19 (2.97 to 9.08)3.9 (2.23 to 6.82)3.64 (2.11 to 6.27)0.18 (0.079 to 0.39)
Day1(serotype III)0.13 (0.08 to 0.2)0.091 (0.057 to 0.15)0.089 (0.055 to 0.15)0.077 (0.049 to 0.12)0.1 (0.064 to 0.16)0.16 (0.1 to 0.26)0.09 (0.057 to 0.14)0.12 (0.074 to 0.19)0.1 (0.05 to 0.2)0.1 (0.066 to 0.17)0.079 (0.05 to 0.13)0.058 (0.037 to 0.092)0.067 (0.042 to 0.11)0.1 (0.066 to 0.16)0.11 (0.067 to 0.17)0.078 (0.049 to 0.12)0.093 (0.059 to 0.15)0.068 (0.036 to 0.13)
Day361(Serotype III)3.05 (1.78 to 5.2)2.71 (1.57 to 4.69)2.45 (1.38 to 4.34)2.78 (1.61 to 4.81)1.77 (1.02 to 3.07)4.48 (2.59 to 7.76)1.77 (1.03 to 3.03)3.46 (1.98 to 6.04)0.13 (0.054 to 0.3)2.33 (1.42 to 3.8)2.67 (1.64 to 4.34)2.06 (1.27 to 3.34)4.5 (2.78 to 7.26)2.62 (1.62 to 4.23)4.99 (3.05 to 8.17)3.07 (1.87 to 5.02)3.51 (2.17 to 5.67)0.076 (0.038 to 0.15)
PrimaryGeometric 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.

Time frame:
Day 1 and day 361
Reported as:
Geometric mean · Ratios
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
Ratios5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 15µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Day361/Day1(Serotype Ia)9.13 (5.74 to 15)10 (6.09 to 17)9.89 (5.87 to 17)15 (8.9 to 24)14 (8.3 to 23)11 (6.58 to 18)8.93 (5.43 to 15)9.54 (5.8 to 16)0.93 (0.43 to 2.01)6.75 (4.44 to 10)7.15 (4.73 to 11)7.99 (5.29 to 12)20 (13 to 30)6.17 (4.09 to 9.33)16 (10 to 24)7.29 (4.8 to 11)9.83 (6.54 to 15)0.9 (0.51 to 1.59)
Day361/Day1(Serotype Ib)28 (19 to 40)37 (26 to 55)26 (18 to 38)38 (26 to 55)23 (16 to 34)38 (26 to 55)27 (19 to 39)30 (21 to 44)3.97 (2.19 to 7.19)23 (16 to 33)37 (26 to 53)27 (18 to 39)54 (38 to 76)26 (18 to 37)45 (31 to 66)49 (34 to 71)35 (25 to 50)1.75 (1.04 to 2.94)
Day361/Day1(Serotype III)24 (16 to 35)30 (20 to 45)27 (17 to 41)35 (23 to 53)17 (12 to 26)30 (20 to 45)20 (13 to 29)31 (20 to 47)1.4 (0.72 to 2.72)22 (15 to 33)35 (23 to 53)35 (24 to 53)65 (44 to 97)26 (18 to 40)45 (30 to 68)38 (26 to 58)38 (26 to 56)1.24 (0.7 to 2.21)
SecondaryNumber 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.

Time frame:
Day 1 to Day 7
Reported as:
Number · participants
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
participants5µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Any Local33373640373839398
Inj site Induration5127128914143
Inj site swelling297118107132
Ecchymosis244254552
Redness31188687174
Warmth6171421121417216
Inj site Pain32353540373739395
Any Systemic232823312831303413
Chills2579775165
Nausea886105108135
Malaise11171313171517206
Myalgia61181014107172
Arthralgia135334471
Headache131914231423223010
Fatigue17181821252020229
Rash012121310
Fever (≥ 38C)012151460
SecondaryNumber 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.

Time frame:
Day 1 through Day 721
Reported as:
Number · participants
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
participants5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 1
Any AEs323331273230333216
At least possibly related AEs811111146750
Serious AEs110262202
Medically attended AEs252423182624282711
SecondaryNumber 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.

Time frame:
Day 1 through Day 721
Reported as:
Number · participants
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
participants5µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Any AEs303436382935343216
At least possibly related AEs0656429131
Serious AEs220332621
Medically attended AEs272626272228272610
SecondaryPersistence 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.

Time frame:
Day 1 and Day 721
Reported as:
Geometric mean · µg/mL
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
µg/mL5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 1
Day 1 (serotype Ia)0.63 (0.35 to 1.11)0.45 (0.25 to 0.83)0.39 (0.21 to 0.75)0.34 (0.19 to 0.64)0.55 (0.29 to 1.04)0.49 (0.25 to 0.95)0.56 (0.31 to 1.01)0.34 (0.18 to 0.63)0.37 (0.12 to 1.16)
Day 721 (Serotype Ia)4.69 (2.23 to 9.89)3.48 (1.58 to 7.67)3.11 (1.36 to 7.14)3.18 (1.42 to 7.09)5.1 (2.23 to 12)3.01 (1.27 to 7.11)3.69 (1.69 to 8.03)2.17 (0.97 to 4.85)0.3 (0.068 to 1.34)
Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6)0.16 (0.089 to 0.28)0.11 (0.061 to 0.2)0.094 (0.051 to 0.17)0.11 (0.063 to 0.2)0.18 (0.1 to 0.33)0.13 (0.069 to 0.23)0.14 (0.078 to 0.27)0.085 (0.045 to 0.16)0.88 (0.23 to 3.29)
Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6)2.92 (1.51 to 5.64)2.81 (1.42 to 5.55)1.71 (0.85 to 3.46)2.64 (1.37 to 5.1)2.32 (1.16 to 4.64)2.96 (1.47 to 5.99)2.55 (1.26 to 5.15)1.45 (0.71 to 2.97)1.02 (0.22 to 4.68)
Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6)0.14 (0.083 to 0.23)0.097 (0.058 to 0.16)0.094 (0.053 to 0.17)0.079 (0.047 to 0.13)0.12 (0.069 to 0.21)0.16 (0.095 to 0.28)0.095 (0.057 to 0.16)0.12 (0.07 to 0.21)0.071 (0.021 to 0.24)
Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6)3.19 (1.77 to 5.77)1.89 (1.04 to 3.45)1.7 (0.89 to 3.27)2.16 (1.2 to 3.91)1.26 (0.67 to 2.36)3.87 (2.06 to 7.26)1.44 (0.8 to 2.6)2.68 (1.44 to 4.99)0.054 (0.013 to 0.22)
SecondaryPersistence 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.

Time frame:
Day 1 and Day 721
Reported as:
Geometric mean · µg/mL
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
µg/mL5µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Day 1 (serotype Ia)0.47 (0.27 to 0.81)0.48 (0.27 to 0.83)0.28 (0.16 to 0.49)0.29 (0.17 to 0.51)0.46 (0.27 to 0.79)0.53 (0.3 to 0.93)0.37 (0.21 to 0.62)0.49 (0.28 to 0.84)0.37 (0.17 to 0.79)
Day 721 (Serotype Ia)1.86 (0.9 to 3.83)1.97 (0.95 to 4.11)1.73 (0.83 to 3.6)3.09 (1.49 to 6.44)1.66 (0.82 to 3.39)5.06 (2.4 to 11)1.72 (0.85 to 3.47)3.32 (1.63 to 6.77)0.33 (0.12 to 0.9)
Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9)0.13 (0.074 to 0.23)0.092 (0.051 to 0.17)0.072 (0.04 to 0.13)0.1 (0.058 to 0.19)0.15 (0.08 to 0.27)0.15 (0.077 to 0.28)0.08 (0.045 to 0.14)0.094 (0.054 to 0.16)0.16 (0.055 to 0.46)
Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9)1.7 (0.9 to 3.22)1.72 (0.87 to 3.41)1.16 (0.59 to 2.27)2.99 (1.53 to 5.86)2.5 (1.26 to 4.96)4.23 (2.02 to 8.84)2.47 (1.28 to 4.79)1.93 (1.03 to 3.61)0.21 (0.063 to 0.7)
Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14)0.11 (0.068 to 0.18)0.082 (0.049 to 0.14)0.061 (0.037 to 0.1)0.071 (0.043 to 0.12)0.09 (0.054 to 0.15)0.12 (0.069 to 0.2)0.077 (0.048 to 0.12)0.1 (0.06 to 0.17)0.061 (0.028 to 0.13)
Day721(Serotype III;N=34,32,34,32,33,31,36,33,14)1.72 (1 to 2.96)1.59 (0.91 to 2.79)1.29 (0.75 to 2.23)2.48 (1.42 to 4.33)2.04 (1.17 to 3.53)3.18 (1.8 to 5.61)1.78 (1.05 to 3.02)2.05 (1.18 to 3.56)0.075 (0.032 to 0.17)
SecondaryGeometric 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.

Time frame:
Day 1 and Day 721
Reported as:
Geometric mean · Ratios
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
Ratios5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 1
Day 721/Day 1(Serotype Ia)7.5 (4.51 to 12)7.67 (4.47 to 13)7.89 (4.48 to 14)9.24 (5.34 to 16)9.25 (5.25 to 16)6.15 (3.42 to 11)6.64 (3.9 to 11)6.35 (3.67 to 11)0.82 (0.3 to 2.26)
Day 721/ Day 1 (Serotype Ib)19 (12 to 28)26 (17 to 40)18 (12 to 29)24 (15 to 36)13 (8.16 to 20)23 (15 to 37)18 (11 to 28)17 (11 to 27)1.17 (0.44 to 3.1)
Day 721/ Day 1 (Serotype III)23 (15 to 35)19 (13 to 30)18 (11 to 29)27 (18 to 41)11 (6.81 to 16)24 (15 to 37)15 (10 to 23)22 (14 to 35)0.76 (0.28 to 2.06)
SecondaryGeometric 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.

Time frame:
Day 1 and Day 721
Reported as:
Geometric mean · Ratios
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
Ratios5µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Day 721/Day 1 (Serotype Ia)3.98 (2.55 to 6.2)4.14 (2.64 to 6.5)6.12 (3.9 to 9.6)11 (6.74 to 17)3.61 (2.33 to 5.6)9.61 (6.09 to 15)4.7 (3.05 to 7.23)6.8 (4.39 to 11)0.89 (0.48 to 1.65)
Day 721/Day 1 (Serotype Ib)13 (8.76 to 20)19 (12 to 29)16 (10 to 24)29 (19 to 44)17 (11 to 26)29 (18 to 45)31 (20 to 47)20 (14 to 30)1.31 (0.61 to 2.8)
Day 721/Day 1 (Serotype III)16 (10 to 24)19 (12 to 30)21 (14 to 33)35 (22 to 54)23 (15 to 35)27 (17 to 43)23 (15 to 35)21 (13 to 32)1.22 (0.62 to 2.4)

Adverse events

Collected over Day 1 through Day 721. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
5µg-1 Inj - No Adj—1/40 (2.5%)37/40 (92.5%)
5µg-2 Inj - No Adj—1/40 (2.5%)38/40 (95%)
20 µg-1 Inj - No Adj—0/39 (0%)38/39 (97.4%)
20 µg-2 Inj - No Adj—2/40 (5%)39/40 (97.5%)
5µg-1 Inj - Alum—6/40 (15%)39/40 (97.5%)
5µg-2 Inj - Alum—2/40 (5%)39/40 (97.5%)
20 µg-1 Inj - Alum—2/39 (5.1%)39/39 (100%)
20 µg-2 Inj- Alum—0/40 (0%)39/39 (100%)
Placebo - Group 1—2/20 (10%)18/19 (94.7%)
5µg-1 Inj - MF59_H—2/40 (5%)38/40 (95%)
5µg-2 Inj - MF59_H—2/40 (5%)37/40 (92.5%)
20 µg-1 Inj - MF59_H—0/40 (0%)40/40 (100%)
20 µg-2 Inj - MF59_H—3/40 (7.5%)40/40 (100%)
5µg-1 Inj - MF59_F—3/40 (7.5%)39/40 (97.5%)
5µg-2 Inj - MF59_F—2/40 (5%)39/40 (97.5%)
20 µg-1 Inj - MF59_F—6/40 (15%)40/40 (100%)
20 µg-2 Inj- MF59_F—2/40 (5%)40/40 (100%)
Placebo - Group 2—1/20 (5%)18/20 (90%)
Most frequent serious events
Showing 10 of 36
Most frequent serious events
Event5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 15µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
AppendicitisInfections and infestations1/400/400/392/400/400/400/390/400/200/401/400/400/400/400/401/400/400/20
Intervertebral Disc DegenerationMusculoskeletal and connective tissue disorders0/400/400/390/400/400/400/390/401/200/400/400/400/400/400/400/400/400/20
Abortion SpontaneousPregnancy, puerperium and perinatal conditions0/401/400/390/400/400/400/390/401/200/400/400/400/401/400/400/400/400/20
Decompression SicknessInjury, poisoning and procedural complications0/400/400/390/400/400/400/390/400/200/400/400/400/400/400/400/400/401/20
MigraineNervous system disorders0/400/400/390/400/400/401/390/400/200/400/400/400/400/400/400/400/400/20
Eating DisorderPsychiatric disorders0/400/400/390/400/400/401/390/400/200/400/400/400/400/400/400/400/400/20
Mitral Valve IncompetenceCardiac disorders0/400/400/390/401/400/400/390/400/200/400/400/400/400/400/400/400/400/20
ConstipationGastrointestinal disorders0/400/400/390/401/400/400/390/400/200/400/400/400/400/400/400/400/400/20
Lyme DiseaseInfections and infestations0/400/400/390/401/400/400/390/400/200/400/400/400/400/400/400/400/400/20
PharyngotonsillitisInfections and infestations0/401/400/390/400/400/400/390/400/200/400/400/400/400/400/400/400/400/20
Most frequent other events
Showing 10 of 61
Most frequent other events
Event5µg-1 Inj - No Adj5µg-2 Inj - No Adj20 µg-1 Inj - No Adj20 µg-2 Inj - No Adj5µg-1 Inj - Alum5µg-2 Inj - Alum20 µg-1 Inj - Alum20 µg-2 Inj- AlumPlacebo - Group 15µg-1 Inj - MF59_H5µg-2 Inj - MF59_H20 µg-1 Inj - MF59_H20 µg-2 Inj - MF59_H5µg-1 Inj - MF59_F5µg-2 Inj - MF59_F20 µg-1 Inj - MF59_F20 µg-2 Inj- MF59_FPlacebo - Group 2
Injection Site PainGeneral disorders28/4028/4031/3935/4039/4037/4038/3939/397/1932/4035/4035/4040/4037/4037/4039/4039/405/20
HeadacheNervous system disorders19/4015/4016/3921/4021/4019/4020/3916/3910/1913/4020/4018/4026/4015/4024/4025/4030/4010/20
FatigueGeneral disorders19/4011/4018/3921/4019/4013/4018/3914/397/1917/4018/4019/4022/4026/4020/4020/4022/409/20
Injection Site WarmthGeneral disorders11/4011/409/3913/4011/4014/4011/3916/391/196/4017/4014/4021/4012/4014/4017/4021/406/20
MalaiseGeneral disorders8/406/4011/3911/408/409/4012/399/392/1911/4017/4013/4014/4017/4015/4017/4020/406/20
Upper Respiratory Tract InfectionInfections and infestations10/407/406/397/408/408/4010/397/394/1911/4014/4010/4015/4016/408/4013/408/4010/20
Injection Site ErythemaGeneral disorders8/408/409/398/409/4012/4015/3915/393/193/4011/408/408/406/408/407/4017/404/20
MyalgiaMusculoskeletal and connective tissue disorders6/402/408/398/403/405/408/397/392/196/4013/4010/4010/4016/4010/407/4017/403/20
Injection Site IndurationGeneral disorders9/4013/407/399/4012/4016/4016/3916/393/195/4012/407/4012/408/409/4014/4014/403/20
Injection Site SwellingGeneral disorders6/406/405/395/407/408/4016/398/392/192/409/407/4011/408/4010/407/4013/402/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)5μg-1 Inj - No Adj5μg-2 Inj - No Adj20 μg-1 Inj - No Adj20 μg-2 Inj - No Adj5μg-1 Inj - Alum5μg-2 Inj - Alum20 μg-1 Inj - Alum20 μg-2 Inj- AlumPlacebo - Group 15μg-1 Inj -MF59_H5μg-2 Inj -MF59_H20 μg-1 Inj -MF59_H20 μg-2 Inj -MF59_H5μg-1 Inj -MF59_F5μg-2 Inj -MF59_F20 μg-1 Inj -MF59_F20 μg-2 Inj-MF59_FPlacebo - Group 2Total
Mean24.3 ± 5.526.2 ± 7.225.5 ± 5.024.1 ± 4.626.5 ± 6.225.1 ± 5.325.1 ± 6.324.3 ± 6.023.5 ± 3.223.4 ± 4.123.5 ± 5.723.5 ± 5.224.7 ± 6.123.6 ± 5.024.9 ± 5.922.7 ± 4.022.9 ± 5.823.5 ± 5.324.3 ± 5.5
Sex: Female, Male
Sex: Female, Male(Participants)5μg-1 Inj - No Adj5μg-2 Inj - No Adj20 μg-1 Inj - No Adj20 μg-2 Inj - No Adj5μg-1 Inj - Alum5μg-2 Inj - Alum20 μg-1 Inj - Alum20 μg-2 Inj- AlumPlacebo - Group 15μg-1 Inj -MF59_H5μg-2 Inj -MF59_H20 μg-1 Inj -MF59_H20 μg-2 Inj -MF59_H5μg-1 Inj -MF59_F5μg-2 Inj -MF59_F20 μg-1 Inj -MF59_F20 μg-2 Inj-MF59_FPlacebo - Group 2Total
Female404039404040394020404040404040404020678
Male0000000000000000000
08

Study locations

1 site
  • Gent, Belgium
09

References and documents

Publications

  • 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. PubMed 26928074 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01150123
Lead sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 24, 2010
Start date
May 2010
Primary completion
Nov 2011
Completion
Oct 2012
Results posted
May 15, 2017
Last update
May 15, 2017

Study contacts

Novartis Vaccines
study chair · Novartis
View the source record on ClinicalTrials.gov ↗

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