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

Invasive Group B Streptococcus (GBS) Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657683
• Other study ID #: V98P1
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2008
• Last updated: December 7, 2011
• Start date: December 2007
• Est. completion date: May 2009

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Invasive Group B Streptococcus (GBS) Disease

Intervention

Biological:
• Monovalent GBS-CRM glycoconjugate vaccine
1 dose of GBS conjugate vaccine
• Placebo
1 dose of placebo

Locations

Country	Name	City	State
Switzerland	Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.	Ligornetto

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To study the magnitude and durability of GBS-specific antibody responses over 12 months.		12 months	No