Phase 1
N=678
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Group B Streptococcus
Bottom Line
View on ClinicalTrials.gov: NCT01150123 ↗Enrolled (actual)
678
Serious AEs
5.5%
Results posted
May 2017
Primary outcome: Primary: Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 — 38; 30; 30; 29 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Group B streptococcus (GBS) vaccine- low dose (Biological); Group B streptococcus (GBS) vaccine- High dose (Biological); Placebo- Saline (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Vaccines
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 |
38; 30; 30; 29; 30; 38 | — |
| PRIMARY Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 |
0.62; 0.51; 0.38; 0.45; 0.48; 0.57 | — |
| PRIMARY Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype |
32; 28; 37; 45; 36; 23 | — |
| PRIMARY Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 |
38; 28; 28; 29; 35; 39 | — |
| PRIMARY Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 |
0.62; 0.45; 0.36; 0.45; 0.53; 0.62 | — |
| PRIMARY Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 |
9.13; 10; 9.89; 15; 14; 11 | — |
| SECONDARY Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 |
30; 32; 31; 35; 39; 37 | — |
| SECONDARY Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 |
33; 37; 36; 40; 37; 38 | — |
| SECONDARY Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 |
32; 33; 31; 27; 32; 30 | — |
| SECONDARY Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 |
30; 34; 36; 38; 29; 35 | — |
| SECONDARY Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 |
0.63; 0.45; 0.39; 0.34; 0.55; 0.49 | — |
| SECONDARY Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 |
0.47; 0.48; 0.28; 0.29; 0.46; 0.53 | — |
| SECONDARY Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 |
7.5; 7.67; 7.89; 9.24; 9.25; 6.15 | — |
| SECONDARY Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 |
3.98; 4.14; 6.12; 11; 3.61; 9.61 | — |
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
Data sourced from ClinicalTrials.gov (NCT01150123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.