A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
Phase 1
Completed
- Conditions
- Invasive Group B Streptococcus (GBS) Disease
- Registration Number
- NCT00657683
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
Inclusion Criteria
- healthy females 18 through 40 years of age;
- have provided written informed consent after the nature of the study has been explained;
- are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
- are in good health as determined by: medical history, physical assessment, clinical judgment of the investigator
Exclusion Criteria
- unwilling or unable to give written informed consent to participate in the study;
- pregnant (serum pregnancy test)
- unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
- nursing (breastfeeding) mothers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events. 1 month
- Secondary Outcome Measures
Name Time Method To study the magnitude and durability of GBS-specific antibody responses over 12 months. 12 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of GBS-CRM glycoconjugate vaccines in eliciting immune responses against Group B Streptococcus capsular polysaccharides?
How does the monovalent GBS-CRM glycoconjugate vaccine compare to multivalent GBS vaccines in safety and immunogenicity profiles for maternal immunization?
Which biomarkers correlate with protective antibody titers after administration of GBS-CRM glycoconjugate vaccines in healthy women 18-40 years?
What are the known adverse events associated with GBS-CRM glycoconjugate vaccines and how are they managed in phase I clinical trials?
Are there any combination vaccine strategies involving GBS-CRM glycoconjugates and other bacterial antigens being explored by Novartis or competitors for maternal immunization?
Trial Locations
- Locations (1)
Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.
🇨🇭Ligornetto, Switzerland
Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.🇨🇭Ligornetto, Switzerland