Group B StreptococcusPhase 1NCT01150123

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

A Phase 1 study testing Group B streptococcus (GBS) vaccine- low dose and Group B streptococcus (GBS) vaccine- High dose in people with Group B Streptococcus, run by Novartis Vaccines at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Group B Streptococcus
What is being tested?: Group B streptococcus (GBS) vaccine- low dose and Group B streptococcus (GBS) vaccine- High dose
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 678 participants
Where: 1 siteBelgium
Study dates: May 2010to Oct 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy females 18-40 years of age inclusive.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Ghent

Other trials in Belgium

About this study

Official title: A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age

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

Conditions: Group B Streptococcus
Being tested: Group B streptococcus (GBS) vaccine- low dose, Group B streptococcus (GBS) vaccine- High dose, Placebo- Saline
Keywords: Group B streptococcus, GBS, Vaccine, Group B streptococcus (GBS) disease
Medical subject headings: Guillain-Barre Syndrome, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group B streptococcus (GBS) vaccine- low doseBiological
Group B streptococcus (GBS) vaccine- High doseBiological
Placebo- SalineBiological

Study groups in NCT01150123
Study group	Role	What they receive
5 µg_No Adj	Experimental	Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_MF59-H	Experimental	Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59 Receives: Biological: Group B streptococcus (GBS) vaccine- High dose
5 µg_MF59-F	Experimental	Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59 Receives: Biological: Group B streptococcus (GBS) vaccine- low dose
20 µg_MF59-F	Experimental	Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59 Receives: Biological: Group B streptococcus (GBS) vaccine- High dose
Placebo	Placebo comparator	Subjects received 2 injections of placebo administered 1 month apart Receives: Biological: Placebo- Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 and Day 361
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.
Measured: Day 1 and day 361

Secondary outcomes (8)

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.
Measured: Day 1 to Day 7
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.
Measured: Day 1 to Day 7
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.
Measured: Day 1 through Day 721
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.
Measured: Day 1 through Day 721
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.
Measured: Day 1 and Day 721
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.
Measured: Day 1 and Day 721
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.
Measured: Day 1 and Day 721
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.
Measured: Day 1 and Day 721

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Oct 2012

First posted24 Jun 2010 (estimated)
Study startMay 2010
Primary completionNov 2011
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Group B StreptococcusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 678 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01150123
Sponsor's protocol ID: V98_06
Status last verified: May 2017
First submitted: 31 Mar 2010
Last updated: 15 May 2017
Results posted: Yes, on ClinicalTrials.gov

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy
Active, not recruitingPhase 2/3
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
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Group B Streptococcus, Invasive Bacterial Diseases (IBD)
RecruitingObservational study
mulTiplex Immunoassay qualiTy assuRance Panel
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All Group B Streptococcus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age
ClinicalTrials.gov ID: NCT01150123
Acronym / sponsor ID: V98_06
Conditions: Group B Streptococcus
Keywords: Group B streptococcus, GBS, Vaccine, Group B streptococcus (GBS) disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 678 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: May 2010
Primary completion: Nov 2011 (actual)
Study completion: Oct 2012 (actual)
First posted: 24 Jun 2010 (estimated)
Results: Posted 15 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 9

Arm	Type	Receives
5 µg_No Adj	Experimental	Biological: Group B streptococcus (GBS) vaccine- low doseSubjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant
20 µg_No Adj	Experimental	Biological: Group B streptococcus (GBS) vaccine- High doseSubjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant.
5 µg_Alum	Experimental	Biological: Group B streptococcus (GBS) vaccine- low doseSubjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
20 µg_Alum	Experimental	Biological: Group B streptococcus (GBS) vaccine- High doseSubjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
5 µg_MF59-H	Experimental	Biological: Group B streptococcus (GBS) vaccine- low doseSubjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59
20 µg_MF59-H	Experimental	Biological: Group B streptococcus (GBS) vaccine- High doseSubjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59
5 µg_MF59-F	Experimental	Biological: Group B streptococcus (GBS) vaccine- low doseSubjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59
20 µg_MF59-F	Experimental	Biological: Group B streptococcus (GBS) vaccine- High doseSubjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59
Placebo	Placebo comparator	Biological: Placebo- SalineSubjects received 2 injections of placebo administered 1 month apart

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy females 18-40 years of age inclusive.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group B streptococcus (GBS) vaccine- low dose	Biological	5 µg_Alum, 5 µg_MF59-F, 5 µg_MF59-H, 5 µg_No Adj
Group B streptococcus (GBS) vaccine- High dose	Biological	20 µg_Alum, 20 µg_MF59-F, 20 µg_MF59-H, 20 µg_No Adj
Placebo- Saline	Biological	Placebo

Primary outcome

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Time frame: Day 1 and Day 61
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.
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Time frame: Day 1 and 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.
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
Time frame: Day 61/Day 1
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.
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Time frame: Day 1 and Day 361
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.
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Time frame: Day 1 and 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.
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
Time frame: Day 1 and 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.

8 secondary outcomes

Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Time frame: Day 1 to Day 7
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Time frame: Day 1 to Day 7
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
Time frame: Day 1 through Day 721
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
Time frame: Day 1 through Day 721
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Time frame: Day 1 and Day 721
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Time frame: Day 1 and Day 721
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
Time frame: Day 1 and Day 721
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
Time frame: Day 1 and Day 721

Results and safety

Results posted to the registry on 15 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5 µg-1 Inj - No Adj	40	37
5 µg-2 Inj - No Adj	40	38
20 µg-1 Inj - No Adj	39	35
20 µg-2 Inj - No Adj	40	37
5 µg-1 Inj - Alum	40	37
5 µg-2 Inj - Alum	40	34
20 µg-1 Inj - Alum	39	39
20 µg-2 Inj- Alum	40	37
Placebo - Group 1	20	15
5 µg-1 Inj - MF59_H	40	39
5 µg-2 Inj - MF59_H	40	38
20 µg-1 Inj - MF59_H	40	39
20 µg-2 Inj - MF59_H	40	37
5 µg-1 Inj - MF59_F	40	40
5 µg-2 Inj - MF59_F	40	40
20 µg-1 Inj - MF59_F	40	39
20 µg-2 Inj- MF59_F	40	40
Placebo - Group 2	20	19

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

Time frame: Day 1 and Day 61. Number. Unit: percentage of subjects

Measure	5µg-1 Inj - No Adj n = 40	5µg-2 Inj - No Adj n = 38	20 µg-1 Inj - No Adj n = 35	20 µg-2 Inj - No Adj n = 38	5µg-1 Inj - Alum n = 37	5µg-2 Inj - Alum n = 37	20 µg-1 Inj - Alum n = 38	20 µg-2 Inj- Alum n = 38	Placebo - Group 1 n = 17
Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17)	38	30	30	29	30	38	35	20	18
Day 61 (Serogroup Ia)	98	97	91	95	97	95	87	84	18
Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17)	24	12	18	17	26	16	24	9	18
Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16)	82	95	83	84	78	86	84	64	19
Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17)	18	13	11	13	16	28	16	18	12
Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17)	70	81	77	79	67	86	70	76	12

Population analysed: 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.

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

Time frame: Day 1 and Day 61. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	5µg-1 Inj - No Adj n = 40	5µg-2 Inj - No Adj n = 38	20 µg-1 Inj - No Adj n = 35	20 µg-2 Inj - No Adj n = 38	5µg-1 Inj - Alum n = 37	5µg-2 Inj - Alum n = 37	20 µg-1 Inj - Alum n = 38	20 µg-2 Inj- Alum n = 38	Placebo - Group 1 n = 17
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)

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

Time frame: Day 61/Day 1. Geometric mean (95% Confidence Interval). Unit: Ratios

Measure	5 µg-1 Inj - No Adj n = 40	5 µg-2 Inj - No Adj n = 37	20 µg-1 Inj - No Adj n = 34	20 µg-2 Inj - No Adj n = 38	5 µg-1 Inj - Alum n = 36	5 µg-2 Inj - Alum n = 36	20 µg-1 Inj - Alum n = 37	20 µg-2 Inj- Alum n = 37	Placebo - Group 1 n = 17
serotype Ia; N=40,33,32,35,33,32,34,35,17	32 (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=37,33,33,35,34,32,34,31,16	47 (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 III	26 (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)

Population analysed: Analysis was done on Primary PPS.

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

Time frame: Day 1 and Day 361. Number. Unit: percentage of subjects

Measure	5µg-1 Inj - No Adj n = 40	5µg-2 Inj - No Adj n = 32	20 µg-1 Inj - No Adj n = 32	20 µg-2 Inj - No Adj n = 35	5µg-1 Inj - Alum n = 34	5µg-2 Inj - Alum n = 33	20 µg-1 Inj - Alum n = 34	20 µg-2 Inj- Alum n = 36	Placebo - Group 1 n = 17	5µg-1 Inj - MF59_H n = 37	5µg-2 Inj - MF59_H n = 38	20 µg-1 Inj - MF59_H n = 38	20 µg-2 Inj - MF59_H n = 39	5µg-1 Inj - MF59_F n = 38	5µg-2 Inj - MF59_F n = 37	20 µg-1 Inj - MF59_F n = 38	20 µg-2 Inj- MF59_F n = 39	Placebo - Group 2 n = 20
Day 1 (Serogroup Ia)	38	28	28	29	35	39	35	22	18	30	29	16	28	29	38	21	31	20
Day 361 (Serogroup Ia)	85	78	88	86	86	92	79	75	14	78	82	76	95	69	92	76	90	20
Day 1 (Serogroup Ib)	24	13	15	17	26	15	24	9	18	24	15	6	26	23

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 721. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5µg-1 Inj - No Adj	1 of 40 (2.5%)	37 of 40 (92.5%)	Not reported
5µg-2 Inj - No Adj	1 of 40 (2.5%)	38 of 40 (95%)	Not reported
20 µg-1 Inj - No Adj	0 of 39 (0%)	38 of 39 (97.4%)	Not reported
20 µg-2 Inj - No Adj	2 of 40 (5%)	39 of 40 (97.5%)	Not reported
5µg-1 Inj - Alum	6 of 40 (15%)	39 of 40 (97.5%)	Not reported
5µg-2 Inj - Alum	2 of 40 (5%)	39 of 40 (97.5%)	Not reported
20 µg-1 Inj - Alum	2 of 39 (5.1%)	39 of 39 (100%)	Not reported
20 µg-2 Inj- Alum	0 of 40 (0%)	39 of 39 (100%)	Not reported
Placebo - Group 1	2 of 20 (10%)	18 of 19 (94.7%)	Not reported
5µg-1 Inj - MF59_H	2 of 40 (5%)	38 of 40 (95%)	Not reported
5µg-2 Inj - MF59_H	2 of 40 (5%)	37 of 40 (92.5%)	Not reported
20 µg-1 Inj - MF59_H	0 of 40 (0%)	40 of 40 (100%)	Not reported
20 µg-2 Inj - MF59_H	3 of 40 (7.5%)	40 of 40 (100%)	Not reported
5µg-1 Inj - MF59_F	3 of 40 (7.5%)	39 of 40 (97.5%)	Not reported
5µg-2 Inj - MF59_F	2 of 40 (5%)	39 of 40 (97.5%)	Not reported
20 µg-1 Inj - MF59_F	6 of 40 (15%)	40 of 40 (100%)	Not reported
20 µg-2 Inj- MF59_F	2 of 40 (5%)	40 of 40 (100%)	Not reported
Placebo - Group 2	1 of 20 (5%)	18 of 20 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26928074Leroux-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines study chair

Novartis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 (time frame: Day 1 and Day 61). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01150123, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.