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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

NCT ID: NCT00657683

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Invasive Group B Streptococcus (GBS) Disease

Keywords

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GBS GBS prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Monovalent GBS-CRM glycoconjugate vaccine

Intervention Type BIOLOGICAL

1 dose of GBS conjugate vaccine

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

1 dose of placebo

Interventions

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Monovalent GBS-CRM glycoconjugate vaccine

1 dose of GBS conjugate vaccine

Intervention Type BIOLOGICAL

Placebo

1 dose of placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.

Ligornetto, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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V98P1

Identifier Type: -

Identifier Source: org_study_id