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

This study has been terminated.

(This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates)

Sponsor:

Information provided by:

Solvay Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00562237

First received: November 20, 2007

Last updated: October 24, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

November 20, 2007

Last Updated Date

October 24, 2008

Start Date ^ICMJE

July 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hemagglutination inhibition titers [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Hemagglutination inhibition titers [ Time Frame: one year ]

Change History

Complete list of historical versions of study NCT00562237 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CHMP criteria [ Time Frame: one year ] [ Designated as safety issue: No ]
Virus neutralization [ Time Frame: one year ] [ Designated as safety issue: No ]
Anti-HA antibody level kinetics [ Time Frame: one year ] [ Designated as safety issue: No ]
Safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Healthy Subjects

Intervention ^ICMJE

Biological: S205 placebo
2 i.m. injections per subject (0.5 mL each)
Biological: S205 10ugHA
2 i.m. injections per subject (0.5 mL each)
Biological: S205 30ugHA
2 i.m. injections per subject (0.5 mL each)
Biological: S205 10ugHA+500ugAlOH
2 i.m. injections per subject (0.5 mL each)
Biological: S205 30ugHA+500ugAlOH
2 i.m. injections per subject (0.5 mL each)
Biological: S205 10ugHA+1250ugAlOH
2 i.m. injections per subject (0.5 mL each)
Biological: S205 30ugHA+1250ugAlOH
2 i.m. injections per subject (0.5 mL each)

Study Arm (s)

Placebo Comparator: 1
Intervention: Biological: S205 placebo
Experimental: 2
Intervention: Biological: S205 10ugHA
Experimental: 3
Intervention: Biological: S205 30ugHA
Experimental: 4
Intervention: Biological: S205 10ugHA+500ugAlOH
Experimental: 5
Intervention: Biological: S205 30ugHA+500ugAlOH
Experimental: 6
Intervention: Biological: S205 10ugHA+1250ugAlOH
Experimental: 7
Intervention: Biological: S205 30ugHA+1250ugAlOH

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

September 2008

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 49 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland, Germany

Administrative Information

NCT Number ^ICMJE

NCT00562237

Other Study ID Numbers ^ICMJE

S205.1.001, 2007-000876-17

Has Data Monitoring Committee

Responsible Party

Joost Melis, Solvay Pharmaceuticals

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top