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Monovalent GBS-CRM glycoconjugate vaccine

Phase 1

Invasive Group B Streptococcus (GBS) Disease | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

Monovalent GBS-CRM glycoconjugate vaccine · 1 trial · 1 indication

Phase 1 1
NCT00657683A 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 AgeInvasive Group B Streptococcus (GBS) Disease
COMPLETED65 Analytics
PHASE1COMPLETED
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
Invasive Group B Streptococcus (GBS) Disease
NCT0065768365
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Study Endpoints

Primary Endpoints

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 Endpoints

To study the magnitude and durability of GBS-specific antibody responses over 12 months.
12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Monovalent GBS-CRM glycoconjugate vaccineBIOLOGICAL1 dose of GBS conjugate vaccine
PlaceboBIOLOGICAL1 dose of placebo
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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 ...

Countries:Switzerland
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Frequently asked questions about Monovalent GBS-CRM glycoconjugate vaccine

What is the Monovalent GBS-CRM glycoconjugate vaccine used for?

The Monovalent GBS-CRM glycoconjugate vaccine is an investigational vaccine being developed for the prevention of invasive Group B Streptococcus (GBS) disease, a serious bacterial infection that can cause sepsis and meningitis, particularly in newborns. It is currently in Phase 1 clinical development.

What does the Monovalent GBS-CRM glycoconjugate vaccine target?

The Monovalent GBS-CRM glycoconjugate vaccine targets Group B Streptococcus (GBS) bacteria. It is designed to elicit an immune response against the GBS capsular polysaccharide by conjugating it to the CRM carrier protein, thereby preventing invasive GBS disease.

Who makes the Monovalent GBS-CRM glycoconjugate vaccine?

The Monovalent GBS-CRM glycoconjugate vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in Phase 1 clinical development.

What phase is the Monovalent GBS-CRM glycoconjugate vaccine in?

The Monovalent GBS-CRM glycoconjugate vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. One Phase 1 trial has been completed to evaluate its safety and immunogenicity.

What clinical trials is the Monovalent GBS-CRM glycoconjugate vaccine in?

The Monovalent GBS-CRM glycoconjugate vaccine has been studied in one completed clinical trial, registered as NCT00657683. This Phase 1 study was a randomized, single-blind, placebo-controlled trial that enrolled 65 healthy women aged 18 to 40 years in Switzerland to evaluate the vaccine's safety and immunogenicity.

Is the Monovalent GBS-CRM glycoconjugate vaccine the same as a GBS vaccine?

The Monovalent GBS-CRM glycoconjugate vaccine is a specific type of Group B Streptococcus (GBS) vaccine. It is a monovalent glycoconjugate vaccine designed to protect against invasive GBS disease, and it is currently in Phase 1 clinical development.