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

A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657683

Enrollment

Registered

2008-04-14

Start date

2007-12-31

Completion date

2009-05-31

Last updated

2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Group B Streptococcus (GBS) Disease

Keywords

GBS, GBS prevention

Brief summary

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.

Interventions

BIOLOGICALMonovalent GBS-CRM glycoconjugate vaccine

1 dose of GBS conjugate vaccine

BIOLOGICALPlacebo

1 dose of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To study the magnitude and durability of GBS-specific antibody responses over 12 months.	12 months

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026