Testing a vaccine in pregnant woman to protect their newborn babies from blood poisoning caused by a bacterium
Phase 1
- Conditions
- Invasive group B streptococcus diseaseMedDRA version: 13.1Level: PTClassification code 10053588Term: Group B streptococcus neonatal sepsisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2010-020840-36-BE
- Lead Sponsor
- ovartis Vaccines and Diagnostics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Healthy pregnant women 18-40 years of age inclusive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Women at risk for poor obstetrical outcome at screening such as gestational diabetes, pre-eclampsia / eclampsia, women at risk of pre-term labor, and history of previous obstetrical complications including delivery of pre-term infant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method