Phase 2
N=697
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Streptococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01193920 ↗Enrolled (actual)
697
Serious AEs
24.9%
Results posted
May 2014
Primary outcome: Primary: The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. — 91; 37; 91; 32 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Group B Streptococcus Trivalent Vaccine - 20/20/20 μg (Biological); Saline solution (Other); Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg (Biological); Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg (Biological); Group B Streptococcus Trivalent Vaccine - 5/5/5 μg (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Vaccines
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. |
91; 37; 91; 32; 88; 26 | — |
| PRIMARY Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. |
40; 0.88; 5.3; 0.25; 11; 0.61 | — |
| PRIMARY The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. |
86; 83; 89; 38; 78; 74 | — |
| PRIMARY Antibody GMC in Maternal Subjects at Day of Delivery |
9.95; 14; 24; 0.67; 2.5; 4.3 | — |
| SECONDARY The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. |
85; 77; 88; 33; 79; 77 | — |
| SECONDARY Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination |
13; 15; 26; 0.62; 2.78; 5.42 | — |
| SECONDARY The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. |
86; 30; 76; 30; 76; 25 | — |
| SECONDARY Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination |
15; 0.86; 5.28; 0.4; 7.03; 0.3 | — |
| SECONDARY Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events |
40; 19; 30; 16 | — |
| SECONDARY Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events |
59; 46; 59; 57; 70; 59 | — |
| SECONDARY Antibody GMC Per Serotype at Different Time Points in Infants |
6.66; 6.52; 12; 0.49; 3.21; 2.95 | — |
| SECONDARY Number of Infants Reporting Serious Adverse Events |
19; 13; 13; 18; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01193920). 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.