Streptococcal InfectionsPhase 1/2NCT01193920

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

A Phase 1/2 study testing Group B Streptococcus Trivalent Vaccine - 20/20/20 μg, Saline solution and Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg in people with Streptococcal Infections, run by Novartis Vaccines at 1 site in South Africa.

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 at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women. 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: Streptococcal Infections
What is being tested?: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg, Saline solution and Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 380 participants
Where: 1 siteSouth Africa
Study dates: Oct 2010to Dec 2012
Phase: Phase 1/2
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

Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)

Who cannot join

Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Chris Hani Baragwanath Hospital
Chris Hani Rd, Soweto, Johannesburg

Other trials in South Africa

About this study

Official title: A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

Conditions: Streptococcal Infections
Being tested: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg, Saline solution, Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg, Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg, Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
Keywords: Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection
Medical subject headings: Streptococcal Infections

What participants receive

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

Group B Streptococcus Trivalent Vaccine - 20/20/20 μgBiological
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Saline solutionOther
Subjects received two injection of saline solution.
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μgBiological
Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μgBiological
Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Group B Streptococcus Trivalent Vaccine - 5/5/5 μgBiological
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
saline solutionOther
Subjects received one injection of saline solution.

Study groups in NCT01193920
Study group	Role	What they receive
1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg	Experimental	Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum. Receives: Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
2: Placebo - Sterile saline	Placebo comparator	Non-Pregnant Women who received two injection of saline solution. Receives: Other: Saline solution
3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg	Experimental	Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. Receives: Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg	Experimental	Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. Receives: Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
5: GBS Trivalent Vaccine - 5/5/5 µg	Experimental	Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. Receives: Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
6: Placebo - Sterile saline	Placebo comparator	Pregnant Women who received one injection of saline solution. Receives: Other: saline solution

What is being measured

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

The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Measured: Day 61, one month after the second vaccination
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
Measured: Day 61, one month after the second vaccination
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Measured: Day of delivery
Antibody GMC in Maternal Subjects at Day of Delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
Measured: Day of delivery

Secondary outcomes (8)

The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Measured: Day 31, one month after vaccination
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
Measured: day 31
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
Measured: Day 361, one year after the first vaccination
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
Measured: Day 361, one year after the first vaccination
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Measured: Day 61
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
Measured: From day 1 to one year after delivery
Antibody GMC Per Serotype at Different Time Points in Infants
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Measured: Day 4, day 43 and day 91 after birth
Number of Infants Reporting Serious Adverse Events
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
Measured: one year after birth

Timeline

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

Oct 2010Dec 2012

First posted2 Sep 2010 (estimated)
Study startOct 2010
Primary completionDec 2011
Study completionDec 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 (3)Papers the sponsor has linked to this study.
Other trials for Streptococcal InfectionsStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193920
Sponsor's protocol ID: V98_08
Other IDs: MCC Reference n° 20100601
Status last verified: Aug 2014
First submitted: 1 Sep 2010
Last updated: 22 Aug 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, Olugbosi M, Sobanjo-Ter Meulen A, Baker S, Dull PM, Narasimhan V, Slobod K. Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy. Clin Infect Dis. 2017 Nov 13;65(11):1897-1904. doi: 10.1093/cid/cix666.
PubMed 29029127
Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.
PubMed 27139805
Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.
PubMed 26409812

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?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa
ClinicalTrials.gov ID: NCT01193920
Acronym / sponsor ID: V98_08
Conditions: Streptococcal Infections
Keywords: Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 380 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2012 (actual)
First posted: 2 Sep 2010 (estimated)
Results: Posted 5 May 2014

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 at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg	Experimental	Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μgNon-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
2: Placebo - Sterile saline	Placebo comparator	Other: Saline solutionNon-Pregnant Women who received two injection of saline solution.
3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg	Experimental	Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μgPregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg	Experimental	Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μgPregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
5: GBS Trivalent Vaccine - 5/5/5 µg	Experimental	Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μgPregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
6: Placebo - Sterile saline	Placebo comparator	Other: saline solutionPregnant Women who received one injection of saline solution.

Who may qualify

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

Key inclusion criteria (2 listed)

Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)

Key exclusion criteria (2 listed)

Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive

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 Trivalent Vaccine - 20/20/20 μgSubjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.	Biological	1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg
Saline solutionSubjects received two injection of saline solution.	Other	2: Placebo - Sterile saline
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μgSubjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.	Biological	3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg
Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μgSubjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.	Biological	4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg
Group B Streptococcus Trivalent Vaccine - 5/5/5 μgSubjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.	Biological	5: GBS Trivalent Vaccine - 5/5/5 µg
saline solutionSubjects received one injection of saline solution.	Other	6: Placebo - Sterile saline

Primary outcome

The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Time frame: Day 61, one month after the second vaccination
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Time frame: Day 61, one month after the second vaccination
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Time frame: Day of delivery
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody GMC in Maternal Subjects at Day of Delivery
Time frame: Day of delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.

8 secondary outcomes

The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
Time frame: Day 31, one month after vaccination
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Time frame: day 31
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Time frame: Day 361, one year after the first vaccination
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Time frame: Day 361, one year after the first vaccination
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Time frame: Day 61
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Time frame: From day 1 to one year after delivery
Antibody GMC Per Serotype at Different Time Points in Infants
Time frame: Day 4, day 43 and day 91 after birth
Number of Infants Reporting Serious Adverse Events
Time frame: one year after birth

Results and safety

Results posted to the registry on 5 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-pregnant 20/20/20 μg +Aluminum Hydroxide	40	37
Non-pregnant/Placebo	20	20
Pregnant 0.5/0.5/0.5 μg	80	74
Pregnant 2.5/2.5/2.5 μg	80	76
Pregnant 5/5/5 μg	80	74
Pregnant/Placebo	80	76
Infants 0.5/0.5/0.5 μg	80	74
Infants 2.5/2.5/2.5 μg	80	76
Infants 5/5/5 μg	76	71
Infants / Placebo	81	74

Primary outcome: The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.

Time frame: Day 61, one month after the second vaccination. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Non-pregnant 20/20/20 μg +Aluminum Hydroxide n = 35	Non-pregnant/Placebo n = 19
Serotype Ia >=1 μg/mL (N=34, 19)	91 (76 to 98)	37 (16 to 62)
Serotype Ia >=2 μg/mL (N=34, 19)	91 (76 to 98)	32 (13 to 57)
Serotype Ia >=3 μg/mL (N=34, 19)	88 (73 to 97)	26 (9 to 51)
Serotype Ia >=5 μg/mL (N=34, 19)	79 (62 to 91)	16 (3 to 40)
Serotype Ia >=8 μg/mL (N=34, 19)	76 (59 to 89)	16 (3 to 40)
Serotype Ib >=1 μg/mL (N=33, 17)	73 (54 to 87)	24 (7 to 50)
Serotype Ib >=2 μg/mL (N=33, 17)	67 (48 to 82)	12 (1 to 36)
Serotype Ib >=3 μg/mL (N=33, 17)	64 (45 to 80)	6 (0 to 29)

Population analysed: Full Analysis Set (FAS) - primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61

Primary outcome: Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.

Time frame: Day 61, one month after the second vaccination. Geometric mean (95% Confidence Interval). Unit: concentrations (μg/mL)

Measure	Non-pregnant 20/20/20 μg +Aluminum Hydroxide n = 35	Non-pregnant/Placebo n = 19
Serotype Ia (N=34, 19)	40 (26 to 62)	0.88 (0.49 to 1.59)
Serotype Ib (N=33, 17)	5.3 (2.94 to 9.56)	0.25 (0.12 to 0.55)
Serotype III	11 (6.43 to 19)	0.61 (0.29 to 1.27)

Population analysed: FAS - primary, non-pregnant subjects

Primary outcome: The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.

Time frame: Day of delivery. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Pregnant 0.5/0.5/0.5 μg n = 76	Pregnant 2.5/2.5/2.5 μg n = 77	Pregnant 5/5/5 μg n = 73	Pregnant/Placebo n = 78
Serotype Ia >= 1 μg/mL (N=76,77, 73, 76)	86 (76 to 93)	83 (73 to 91)	89 (80 to 95)	38 (27 to 50)
Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76)	78 (67 to 86)	74 (63 to 83)	81 (70 to 89)	26 (17 to 38)
Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76)	75 (64 to 84)	71 (60 to 81)	77 (65 to 86)	21 (13 to 32)
Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76)	72 (61 to 82)	69 (57 to 79)	75 (64 to 85)	18 (10 to 29)
Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76)	64 (53 to 75)	64 (52 to 74)	71 (59 to 81)	9 (4 to 18)
Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58)	58 (45 to 70)	65 (53 to 76)	65 (53 to 76)	14 (6 to 25)
Serotype Ib >= 2 μg/mL (69, 74, 71, 58)	52 (40 to 64)	51 (39 to 63)	48 (36 to 60)	10 (4 to 21)
Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58)	43 (32 to 56)	49 (37 to 61)	42 (31 to 55)	10 (4 to 21)

Population analysed: FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery

Primary outcome: Antibody GMC in Maternal Subjects at Day of Delivery

Time frame: Day of delivery. Geometric mean (95% Confidence Interval). Unit: Concentration (μg/mL)

Measure	Pregnant 0.5/0.5/0.5 μg n = 76	Pregnant 2.5/2.5/2.5 μg n = 77	Pregnant 5/5/5 μg n = 73	Pregnant/Placebo n = 78
Serotype Ia (N= 76, 77, 73, 76)	9.95 (6.6 to 15)	14 (9.19 to 21)	24 (16 to 36)	0.67 (0.46 to 0.99)
Serotype Ib (N=69, 74, 71, 58)	2.5 (1.61 to 3.88)	4.3 (2.74 to 6.76)	2.93 (1.79 to 4.77)	0.38 (0.25 to 0.59)
Serotype III (N=74, 77, 73, 78)	2.63 (1.8 to 3.85)	3.66 (2.52 to 5.31)	2.83 (1.92 to 4.17)	0.25 (0.18 to 0.34)

Population analysed: FAS primary, maternal subjects

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-pregnant 20/20/20 μg +Aluminum Hydroxide	2 of 40 (5%)	40 of 40 (100%)	Not reported
Non-pregnant/Placebo	1 of 20 (5%)	19 of 20 (95%)	Not reported
Pregnant 0.5/0.5/0.5 μg	27 of 80 (33.8%)	72 of 80 (90%)	Not reported
Pregnant 2.5/2.5/2.5 μg	24 of 80 (30%)	67 of 80 (83.8%)	Not reported
Pregnant 5/5/5 μg	25 of 80 (31.3%)	70 of 80 (87.5%)	Not reported
Pregnant/Placebo	30 of 80 (37.5%)	71 of 80 (88.8%)	Not reported
Infants 0.5/0.5/0.5 μg	19 of 79 (24.1%)	44 of 79 (55.7%)	Not reported
Infants 2.5/2.5/2.5 μg	13 of 79 (16.5%)	49 of 79 (62%)	Not reported
Infants 5/5/5 μg	13 of 74 (17.6%)	48 of 74 (64.9%)	Not reported
Infants / Placebo	18 of 78 (23.1%)	51 of 78 (65.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29029127Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, Olugbosi M, Sobanjo-Ter Meulen A, Baker S, Dull PM, Narasimhan V, Slobod K. Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy. Clin Infect Dis. 2017 Nov 13;65(11):1897-1904. doi: 10.1093/cid/cix666.
Derived from this study: PubMed 27139805Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.
Derived from this study: PubMed 26409812Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.

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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 and Diagnostics 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 2 inclusion and 2 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 22 Aug 2014. 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 South Africa. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 May 2014). 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?

The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. (time frame: Day 61, one month after the second vaccination). The study lists 4 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 NCT01193920, which also lists 3 linked publications.

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 22 Aug 2014.