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Swine Flu (Novel Influenza A H1N1) Vaccine Study

NCT00980850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2013-05-09

No results posted yet for this study

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

Interventions

BIOLOGICAL

Baxter Novel Influenza A H1N1 Whole Virus Vaccine

Two 0.5 ml doses of vaccine given within 3 weeks interval

BIOLOGICAL

GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine

Two 0.25 ml doses of vaccine given within 3 weeks interval

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew Pollard, MRCP, PhD · Oxford Vaccine Group, University of Oxford

  • Liz Miller, FRCPath, DSc · Public Health England

  • Paul Heath, FRCPCH · St Georges Vaccine Institute

  • Adam Finn, PhD, FRCPCH · Bristol Children's Vaccine Centre

  • Saul Faust, MRCPCH, PhD · University of Southampton Wellcome Trust Clinical Research Facility

  • Andrew Collinson, MRCPCH, MD · Royal Devon and Exeter NHS Foundation Trust

  • Matthew Snape, FRCPCH, MD · Oxford Vaccine Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980850 on ClinicalTrials.gov