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

NCT ID: NCT00562237

Last Updated: 2008-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subjects

Keywords

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immunogenicity safety adjuvanted pandemic vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

S205 placebo

Intervention Type BIOLOGICAL

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

2

Group Type EXPERIMENTAL

S205 10ugHA

Intervention Type BIOLOGICAL

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

3

Group Type EXPERIMENTAL

S205 30ugHA

Intervention Type BIOLOGICAL

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

4

Group Type EXPERIMENTAL

S205 10ugHA+500ugAlOH

Intervention Type BIOLOGICAL

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

5

Group Type EXPERIMENTAL

S205 30ugHA+500ugAlOH

Intervention Type BIOLOGICAL

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

6

Group Type EXPERIMENTAL

S205 10ugHA+1250ugAlOH

Intervention Type BIOLOGICAL

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

7

Group Type EXPERIMENTAL

S205 30ugHA+1250ugAlOH

Intervention Type BIOLOGICAL

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

Interventions

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S205 placebo

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

Intervention Type BIOLOGICAL

S205 10ugHA

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

Intervention Type BIOLOGICAL

S205 30ugHA

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

Intervention Type BIOLOGICAL

S205 10ugHA+500ugAlOH

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

Intervention Type BIOLOGICAL

S205 30ugHA+500ugAlOH

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

Intervention Type BIOLOGICAL

S205 10ugHA+1250ugAlOH

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

Intervention Type BIOLOGICAL

S205 30ugHA+1250ugAlOH

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 21

Helsinki, , Finland

Site Status

Site 22

Tampere, , Finland

Site Status

Site 23

Turku, , Finland

Site Status

Site 12

Goch, , Germany

Site Status

Site 10

Hamburg, , Germany

Site Status

Site 11

Nuremberg, , Germany

Site Status

Countries

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Finland Germany

Other Identifiers

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S205.1.001

Identifier Type: -

Identifier Source: org_study_id

2007-000876-17

Identifier Type: -

Identifier Source: secondary_id