Swine Flu (Novel Influenza A H1N1) Vaccine Study

NCT00980850 | Completed Phase 2 DMC

• 1 other identifier: 2009/08 H1N1
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest rates of disease are being seen in young children. In anticipation of an influenza pandemic two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorization approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the "mockup" dossier route based on limited clinical trial data for a candidate H5N1 vaccine. This "mockup" dossier route for pandemic influenza vaccines allows the submission of a core pandemic dossier during the interpandemic period, which results in the approval of a mockup pandemic vaccine. This is followed by a fast track approval of the pandemic vaccine based on the submission of the pandemic variation when the situation arises. The Baxter and GlaxoSmithKline vaccines have now been modified to cover the novel influenza A H1N1 strain. Given the high rates of swine flu disease in children, this age group is likely to particularly benefit from immunization against this virus, however there are few data on the use of these vaccines in a pediatric population. The proposed study therefore aims to assess the immunogenicity, safety, and tolerability of these two H1N1 vaccines when administered as two doses three weeks apart to children aged 6 months to 12 years of age.

Conditions

Influenza

Keywords

Flu vaccine; H1N1 swine flu virus; Immunogenicity; Reactogenicity

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with a 4 fold rise in MN titre between the pre-vaccination sample and sample taken 3 weeks after the second dose

  3 weeks after second vaccine dose

• Percentage of participants experiencing each of fever (≥ 38°C per axilla), local tenderness, local swelling or local erythema within the 7 days following each immunisation with the study vaccines

  Within the 7 days following each immunisation with the study vaccines

Secondary Outcomes (8)

• Percentage of subjects with an HAI titre ≥ 1 in 32

  3 weeks after the second dose

• Percentage of subjects with a 4 fold rise in HAI titre between the pre-vaccination sample and sample taken 3 weeks after the second dose

  3 weeks after the second dose

• The geometric mean fold rises in HAI titres from baseline to after three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.

  3 weeks after the second dose

• The geometric mean fold rises in MN titres from baseline to three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.

  3 weeks after the second dose

• The geometric mean HAI and MN titres three weeks after 2 doses of the Baxter H1N1 vaccine and the GSK H1N1 vaccine.

  3 weeks after the second dose

Study Arms (2)

Groups A1 and A2

EXPERIMENTAL

Baxter vaccine

Biological: Baxter Novel Influenza A H1N1 Whole Virus Vaccine

Groups B1 and B2

EXPERIMENTAL

GSK vaccine

Biological: GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine

Interventions

Baxter Novel Influenza A H1N1 Whole Virus Vaccine BIOLOGICAL

Two 0.5 ml doses of vaccine given within 3 weeks interval

Also known as: Celvapan

Groups A1 and A2

GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine BIOLOGICAL

Two 0.25 ml doses of vaccine given within 3 weeks interval

Also known as: Pandemrix

Groups B1 and B2

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• baby or child aged between 6 months to 12 years of age (i.e., to day before 13th birthday)
• for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained
• available for all the visits scheduled in the study
• willingness to complete all study procedures

You may not qualify if:

• History of any vaccine against novel influenza A strain H1N1 (based on verbal confirmation from parent/guardian)
• Previous laboratory confirmed case of novel influenza A strain H1N1 or treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 (n.b. a child commenced on treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 whose treatment was stopped following negative microbiological tests for H1N1 on nasal swabs would be allowed to enrol in the study\]
• History of severe allergic reaction after previous vaccinations or hypersensitivity to any H1N1 vaccine component
• Current egg allergy
• Known or suspected impairment/alteration of the immune system
• Disorders of coagulation
• Immunosuppressive therapy, use of systemic corticosteroids for more than 1 week within the 3 months prior to enrollment
• Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrollment
• Intent to immunize with any other vaccine(s) against novel influenza A strain H1N1 throughout the study period
• Participation in another clinical trial of an investigational medical product
• Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Children with chronic, stable medical illnesses that do not result in immunosuppression (e.g., cerebral palsy, epilepsy, cystic fibrosis, congenital heart disease) will be allowed to participate in the study, unless these conditions will in some way interfere with the completion of study procedures. Children with conditions that may alter the immune response to vaccines (e.g., Trisomy 21) or will affect the ability to accurately describe adverse events (e.g., children over 5 years of age but with severe learning difficulties) will be excluded

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (5)

Bristol Children's Vaccine Centre

Bristol, Bristol, BS2 8AE, United Kingdom

Location

St Georges Vaccine Institute

London, London, SW17 ORE, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

Oxford Vaccine Group

Oxford, OX3 7LJ, United Kingdom

Location

University of Southampton Wellcome Trust Clinical Research Facility

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (3)

• Andrews NJ, Walker WT, Finn A, Heath PT, Collinson AC, Pollard AJ, Snape MD, Faust SN, Waight PA, Hoschler K, Sheasby L, Waddington C, Kerridge S, Chalk J, Reiner A, John T, Fletcher M, Allen R, Fineman N, Wilkins S, Casey M, Michaelis L, Oeser C, Okike I, Ladhani S, Miller E. Predictors of immune response and reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccines. Vaccine. 2011 Oct 19;29(45):7913-9. doi: 10.1016/j.vaccine.2011.08.076. Epub 2011 Aug 27.

  PMID: 21875635 BACKGROUND

• Waddington CS, Walker WT, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston PE, Allen RJ, Okike I, Ladhani S, Sheasby E, Hoschler K, Andrews N, Waight P, Collinson AC, Heath PT, Finn A, Faust SN, Snape MD, Miller E, Pollard AJ. Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ. 2010 May 27;340:c2649. doi: 10.1136/bmj.c2649.

  PMID: 20508026 BACKGROUND

• Waddington C, Andrews N, Hoschler K, Walker W, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston P, Allen R, Okike I, Ladhani S, Sheasby E, Waight P, Collinson A, Heath P, Finn A, Faust S, Snape M, Miller E, Pollard A. Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03(B)/oil-in-water emulsion-adjuvanted (AS03(B)) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age. Health Technol Assess. 2010 Oct;14(46):1-130. doi: 10.3310/hta14460-01.

  PMID: 20923610 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

pandemrix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Andrew Pollard, MRCP, PhD

  Oxford Vaccine Group, University of Oxford

  STUDY DIRECTOR

• Liz Miller, FRCPath, DSc

  Public Health England

  PRINCIPAL INVESTIGATOR

• Paul Heath, FRCPCH

  St Georges Vaccine Institute

  PRINCIPAL INVESTIGATOR

• Adam Finn, PhD, FRCPCH

  Bristol Children's Vaccine Centre

  PRINCIPAL INVESTIGATOR

• Saul Faust, MRCPCH, PhD

  University of Southampton Wellcome Trust Clinical Research Facility

  PRINCIPAL INVESTIGATOR

• Andrew Collinson, MRCPCH, MD

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Matthew Snape, FRCPCH, MD

  Oxford Vaccine Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

GB (5)