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

Summary

This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.

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

Sponsors & Collaborators

• Medical Research Council

  collaborator OTHER_GOV

• Novartis

  collaborator INDUSTRY

• Public Health England

  collaborator OTHER_GOV

• National Institute of Biological Standards and Control

  collaborator OTHER_GOV

• University Hospitals, Leicester

  lead OTHER

Principal Investigators

• Karl G Nicholson, FRCP, MD · University of Leicester

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2013-09-30

Completion

2013-12-31

Countries

• United Kingdom

Study Locations