Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
NCT ID: NCT01193920
Last Updated: 2014-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
380 participants
INTERVENTIONAL
2010-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg
Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
2: Placebo - Sterile saline
Non-Pregnant Women who received two injection of saline solution.
Saline solution
Subjects received two injection of saline solution.
3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Subjects 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
Pregnant Women who 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 - 2.5/2.5/2.5 μg
Subjects 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
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
6: Placebo - Sterile saline
Pregnant Women who received one injection of saline solution.
saline solution
Subjects received one injection of saline solution.
Interventions
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Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Saline solution
Subjects received two injection of saline solution.
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
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 μg
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 μg
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
saline solution
Subjects received one injection of saline solution.
Eligibility Criteria
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Inclusion Criteria
* Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)
Exclusion Criteria
* Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
18 Years
40 Years
FEMALE
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines and Diagnostics
Role: STUDY_CHAIR
Novartis
Locations
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Chris Hani Baragwanath Hospital
Chris Hani Rd, Soweto, Johannesburg, South Africa
Countries
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References
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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.
Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Meulen AS, Baker S, Dull PM, Narasimhan V, Slobod K. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016 Aug;16(8):923-34. doi: 10.1016/S1473-3099(16)00152-3. Epub 2016 Apr 29.
Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.
Other Identifiers
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MCC Reference n° 20100601
Identifier Type: OTHER
Identifier Source: secondary_id
V98_08
Identifier Type: -
Identifier Source: org_study_id
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