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

Novartis

Status and phase

Completed

Phase 1

Conditions

Invasive Group B Streptococcus (GBS) Disease

Treatments

Biological: Placebo

Biological: Monovalent GBS-CRM glycoconjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00657683

V98P1

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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