Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine

Phase 1TerminatedNCT00562237

Solvay Pharmaceuticals400 enrolled

Overview

Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

400

Conditions

Healthy Subjects

Interventions

S205 placeboBIOLOGICAL

2 i.m. injections per subject (0.5 mL each)

S205 10ugHABIOLOGICAL

2 i.m. injections per subject (0.5 mL each)

S205 30ugHABIOLOGICAL

2 i.m. injections per subject (0.5 mL each)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * being healthy and ≥ 18 and ≤ 49 years of age * willing and able to give informed consent Exclusion Criteria: * having participated in an influenza H5 vaccine trial in the past * known to be allergic to any constituent of the vaccine * serious adverse reactions to previous (influenza) vaccination * currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study * using medication that influences the immune system

Locations (6)

Site 21

Helsinki, Finland

Site 22

Tampere, Finland

Site 23

Turku, Finland

Site 12

Goch, Germany

Site 10

Hamburg, Germany

Outcomes

Primary Outcomes

Hemagglutination inhibition titers

Time frame: one year

Secondary Outcomes

CHMP criteria

Time frame: one year

Virus neutralization

Time frame: one year

Anti-HA antibody level kinetics

Time frame: one year

Safety

Time frame: one year

Data from ClinicalTrials.gov

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