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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 Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age

NCT ID: NCT00645346

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-07-31

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

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

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

Group Type EXPERIMENTAL

GBS glycoconjugate vaccine

Intervention Type BIOLOGICAL

Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.

2

Subjects will receive placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Subjects will receive one dose of placebo

Interventions

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GBS glycoconjugate vaccine

Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.

Intervention Type BIOLOGICAL

Placebo

Subjects will receive one 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

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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Novartis

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.

Ligornetto, Ligornetto, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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V98P2

Identifier Type: -

Identifier Source: org_study_id