Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
NCT ID: NCT01150123
Last Updated: 2017-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
678 participants
INTERVENTIONAL
2010-05-31
2012-10-31
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
SINGLE
Study Groups
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5 µg_No Adj
Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant
Group B streptococcus (GBS) vaccine- low dose
20 µg_No Adj
Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant.
Group B streptococcus (GBS) vaccine- High dose
5 µg_Alum
Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
Group B streptococcus (GBS) vaccine- low dose
20 µg_Alum
Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
Group B streptococcus (GBS) vaccine- High dose
5 µg_MF59-H
Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59
Group B streptococcus (GBS) vaccine- low dose
20 µg_MF59-H
Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59
Group B streptococcus (GBS) vaccine- High dose
5 µg_MF59-F
Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59
Group B streptococcus (GBS) vaccine- low dose
20 µg_MF59-F
Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59
Group B streptococcus (GBS) vaccine- High dose
Placebo
Subjects received 2 injections of placebo administered 1 month apart
Placebo- Saline
Interventions
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Group B streptococcus (GBS) vaccine- low dose
Group B streptococcus (GBS) vaccine- High dose
Placebo- Saline
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis
Locations
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Ghent, , Belgium
Countries
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References
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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.
Other Identifiers
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V98_06
Identifier Type: -
Identifier Source: org_study_id
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