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

NCT00657683 | Completed Phase 1

• 1 other identifier: V98P1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Group B Streptococcus (GBS) Disease

Keywords

GBS; GBS prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 months

Study Arms (2)

1

EXPERIMENTAL

Biological: Monovalent GBS-CRM glycoconjugate vaccine

2

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Monovalent GBS-CRM glycoconjugate vaccine BIOLOGICAL

1 dose of GBS conjugate vaccine

1

Placebo BIOLOGICAL

1 dose of placebo

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

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

Ligornetto, 6853, Switzerland

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome; Disease

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 14, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

CH (1)