Immunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

606

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

September 30, 2013

Study Completion Date

December 31, 2013

Conditions
Influenza
Interventions
BIOLOGICAL

Aflunov (Single prime, single boost)

Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks

BIOLOGICAL

Aflunov (Single prime, single boost)

Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks

BIOLOGICAL

Aflunov (single prime, single boost)

Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks

BIOLOGICAL

Aflunov (single prime, single boost)

Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks

BIOLOGICAL

Aflunov (Double prime, single boost)

Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks

BIOLOGICAL

Aflunov (double prime, single boost)

Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks

BIOLOGICAL

Aflunov (double prime, single boost)

Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks

BIOLOGICAL

Aflunov (double prime, single boost)

Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks

BIOLOGICAL

Aflunov (No prime, single boost)

No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks

Trial Locations (2)

LE1 5WW

University Hospitals Leicester, Leicester

Clincal Trials Unit Leicester Royal Infirmary, Leicester

Sponsors
All Listed Sponsors
collaborator

Medical Research Council

OTHER_GOV

collaborator

Novartis

INDUSTRY

collaborator

Public Health England

OTHER_GOV

collaborator

National Institute of Biological Standards and Control

OTHER_GOV

lead

University Hospitals, Leicester

OTHER