Skip to main content
OpenTrials
Completed

NCT Number: NCT00645346

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Invasive Group B Streptococcus (GBS) Disease Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

Ligornetto, 6853, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GBS glycoconjugate vaccine

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.

Placebo

Biological

Subjects will receive one dose of placebo

Primary outcomes

  1. To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine

    Time frame: 1 month

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 27, 2008
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.