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

Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Surface Antigen Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00562237

Enrollment

400

Registered

2007-11-21

Start date

2007-07-31

Completion date

2008-09-30

Last updated

2008-10-27

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

Conditions

Healthy Subjects

Keywords

immunogenicity, safety, adjuvanted pandemic vaccine

Brief summary

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.

Interventions

BIOLOGICALS205 placebo

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

BIOLOGICALS205 10ugHA

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

BIOLOGICALS205 30ugHA

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

BIOLOGICALS205 10ugHA+500ugAlOH

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

BIOLOGICALS205 30ugHA+500ugAlOH

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

BIOLOGICALS205 10ugHA+1250ugAlOH

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

BIOLOGICALS205 30ugHA+1250ugAlOH

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

Sponsors

Solvay Pharmaceuticals

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Hemagglutination inhibition titers	one year

Secondary

Measure	Time frame
CHMP criteria	one year
Virus neutralization	one year
Anti-HA antibody level kinetics	one year
Safety	one year

Countries

Finland, Germany

Outcome results

None listed

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