An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.

Valneva Austria GmbH1 site in 1 country32 target enrollmentMarch 2009

ConditionsPneumococcal Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pneumococcal Infections
Sponsor: Valneva Austria GmbH
Enrollment: 32
Locations: 1
Primary Endpoint: Occurrence of any SAEs (possibly)related to the study vaccine
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.

A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.

Detailed Description

This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

February 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Valneva Austria GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Healthy adults ≥ 18 to \</= 65
•female subjects: post-menopausal or practicing reliable methods of contraception during the study