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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00873431

Enrollment

Registered

2009-04-01

Start date

2009-03-31

Completion date

2010-02-28

Last updated

2012-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

Keywords

Prevention of pneumococcal infections

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.

Interventions

BIOLOGICALIC47

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* History of autoimmune diseases and malignancies. * History of severe hypersensitivity reactions and anaphylaxis. * Immunodeficiency due to immunosuppressive therapy. * Infection with HIV, Hepatitis B or Hepatitis C. * Pregnancy, lactation * Vulnerable subjects

Design outcomes

Primary

Measure	Time frame
Occurrence of any SAEs (possibly)related to the study vaccine	Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine	Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination	Day 0 - Day 264

Secondary

Measure	Time frame
Determination of vaccine-specific IgG levels	Day 0 - Day 264

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026