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| Sponsor: | University Hospitals, Leicester |
|---|---|
| Collaborators: |
Medical Research Council Novartis Health Protection Agency, United Kingdom National Institute of Biological Standards and Control |
| Information provided by: | University Hospitals, Leicester |
| ClinicalTrials.gov Identifier: | NCT00814385 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Aflunov (Single prime, single boost) Biological: Aflunov (single prime, single boost) Biological: Aflunov (Double prime, single boost) Biological: Aflunov (double prime, single boost) Biological: Aflunov (No prime, single boost) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) |
| Official Title: | A Randomized, Partially Observer-blind, Single-centre Study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Influenza Vaccines in Adults Primed With Adjuvanted Influenza A/Vietnam/1194/04 (H5N1) Vaccine |
| Estimated Enrollment: | 780 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vaccine arm 1
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose 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 3.75microg at 52 weeks
Other Name: Aflunov
|
|
Active Comparator: Vaccine arm 2
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose 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
Other Name: Aflunov
|
|
Active Comparator: Vaccine arm 3
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose 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
Other Name: Aflunov
|
|
Active Comparator: Vaccine arm 4
Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose 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
Other Name: aflunov
|
|
Active Comparator: Vaccine arm 5
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose 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
Other Name: aflunov
|
|
Active Comparator: vaccine arm 6
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose 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
Other Name: aflunov
|
|
Active Comparator: Vaccine arm 7
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose 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
Other Name: aflunov
|
|
Active Comparator: Vaccine arm 8
Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose 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
Other Name: aflunov
|
|
Active Comparator: Vaccine arm 9
No priming dose and single dose MF59 adjuvanted H5N1 vaccine at 52 weeks
|
Biological: Aflunov (No prime, single boost)
No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks
Other Name: aflunov
|
OBJECTIVES:
Immunogenicity objectives
Safety objective
1. To evaluate the safety of the administration of one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (each dose containing 7.5μg of H5N1 haemagglutinin), in immunologically naïve subjects, followed by one 3.75μg or 7.5μg 'booster' dose of antigenically drifted MF59-adjuvanted H5N1 vaccine, or non-adjuvanted antigenically drifted H5N1 vaccine.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Are in good health or have one or more stable (See footnote) medical conditions, as determined by:
Subjects with any serious disease, including:
Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
Exclusion Criteria:
Contacts and Locations| Contact: Karl G Nicholson, FRCP, MD | +44 116 258 6952 ext 6164 | karl.nicholson@uhl-tr.nhs.uk |
| Contact: Iain Stephenson, FRCP | +44 116 258 6952 | iain.stephenson@uhl-tr.nhs.uk |
| United Kingdom | |
| University Hospitals Leicester | Recruiting |
| Leicester, Leicestershire, United Kingdom, LE1 5WW | |
| Contact: John Hampton, PhD +44 116 2490490 john.hampton@uhl-tr.nhs.uk | |
| Principal Investigator: Karl G Nicholson, FRCP | |
| Sub-Investigator: Iain Stephenson, FRCP | |
| Principal Investigator: | Karl G Nicholson, FRCP, MD | University of Leicester |
More Information
| Responsible Party: | Mr J Hampton, University of Leicester NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00814385 History of Changes |
| Other Study ID Numbers: | UHL10492 |
| Study First Received: | December 23, 2008 |
| Last Updated: | July 20, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |