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

Solvay

Status and phase: Terminated; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: S205 10ugHA+1250ugAlOH; Biological: S205 placebo; Biological: S205 30ugHA+1250ugAlOH; Biological: S205 30ugHA+500ugAlOH; Biological: S205 10ugHA; Biological: S205 10ugHA+500ugAlOH; Biological: S205 30ugHA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562237

2007-000876-17

S205.1.001

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 7 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Biological: S205 placebo

2

Experimental group

Treatment:

Biological: S205 10ugHA

3

Experimental group

Treatment:

Biological: S205 30ugHA

4

Experimental group

Treatment:

Biological: S205 10ugHA+500ugAlOH

5

Experimental group

Treatment:

Biological: S205 30ugHA+500ugAlOH

6

Experimental group

Treatment:

Biological: S205 10ugHA+1250ugAlOH

7

Experimental group

Treatment:

Biological: S205 30ugHA+1250ugAlOH