A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of 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: GBS glycoconjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645346

V98P2

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: 130 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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Subjects will receive either 5, 10 or 20 mcg of the vaccine

Treatment:

Biological: GBS glycoconjugate vaccine

2

Placebo Comparator group

Description:

Subjects will receive placebo control

Treatment:

Biological: Placebo