Clinical trial NCT01150123: Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Group B Streptococcus
Keywords: Group B streptococcus
GBS
Vaccine
Group B streptococcus (GBS) disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-06-24
Enrollment: 678
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* Healthy females 18-40 years of age inclusive.

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

Primary outcomes:
measure: Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
timeFrame: Day 1 and Day 61
measure: Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
timeFrame: Day 1 and Day 61
measure: Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
timeFrame: Day 61/Day 1
measure: Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
timeFrame: Day 1 and Day 361
measure: Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
timeFrame: Day 1 and Day 361
measure: Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
timeFrame: Day 1 and day 361
Secondary outcomes:
measure: Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
timeFrame: Day 1 to Day 7
measure: Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
timeFrame: Day 1 to Day 7
measure: Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
timeFrame: Day 1 through Day 721
measure: Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
timeFrame: Day 1 through Day 721
measure: Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
timeFrame: Day 1 and Day 721
measure: Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
timeFrame: Day 1 and Day 721
measure: Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
timeFrame: Day 1 and Day 721
measure: Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
timeFrame: Day 1 and Day 721
Other outcomes:
Locations:
city: Gent
country: Belgium
Study officials:
affiliation: Novartis
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: 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.