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Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47

NCT00873431 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-10-19

No results posted yet for this study

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.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

IC47

solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Evelyn Hatzenbichler, PhD · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00873431 on ClinicalTrials.gov