NCT02459262

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.

A Two-part, Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of a Dose Range og Group B Streptococcus Vaccine in Healthy Female Volunteers Aged 18 to 40.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Minervax ApS · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus. Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the first dose.

Detailed description

Part A: Subjects will receive 2 doses of the vaccine, GBS-NN, and will be followed for 12 weeks after the first dose of the vaccine. The following safety endpoints will be evaluated to support this objective: local and systemic reactogenicity; adverse events; laboratory tests; urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition hereto, immunological parameters will be evaluated. Part B: Subjects will receive one or 2 doses of GBS-NN, and will be followed for 12 months after the first dose of the vaccine. The following safety endpoints will be evaluated to support this objective: local and systemic reactogenicity; adverse events; laboratory tests; urinalysis; vital signs; 12-Lead ECG parameters; physical examination. In addition hereto, immunological parameters will be evaluated.

Conditions

• Infection by Streptococcus Group B

Interventions

Type	Name	Description
BIOLOGICAL	GBS-NN vaccine	Three dose levels will be administered, with and without Alhydrogel®

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-04-12
• Completion: 2017-04-21
• First posted: 2015-06-02
• Last updated: 2021-01-14
• Results posted: 2021-01-14

Locations

1 site across 1 country: United Kingdom