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Swine Flu (Influenza A H1N1) Follow on Vaccine Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01239537
First received: November 10, 2010
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

In 2009 the World Health Organization (WHO) declared the Influenza A H1N1 (swine 'flu) outbreak the first global pandemic of this century. It is thought to have been responsible for 16,226 deaths globally as of 21st February 2010. The investigators know from previous influenza outbreaks that the number of cases also tends to increase during the winter season of the years after a pandemic. There is concern that last year's pandemic influenza strain will return this winter and it has, therefore, been included in WHO's recommendations for seasonal influenza vaccine combinations.

This study will assess the duration of the immune response to the H1N1 influenza vaccines given last year, and how children will respond to this year's seasonal trivalent influenza vaccine (which includes the H1N1 strain). Participating children would receive one dose of a licensed seasonal influenza vaccine and blood tests would be taken before and after vaccination.


Condition Intervention
Influenza
Drug: Seasonal Flu vaccine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-centre, Open-label, Clinical, Phase 4 Trial, Following on From a Head-to-head Comparison Study of Two H1N1 Influenza Vaccines in Children, to Compare Firstly, the Persistence of Antibody Against the A/California/7/2009 (H1N1) Virus and Secondly the Immunogenicity and Reactogenicity of One Dose of a Non-adjuvanted Trivalent Seasonal Influenza Vaccine, in Children Who Had Received a Two-dose Immunisation Regimen of Celvapan or Pandemrix.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Persistence of MICRONEUTRALISING antibody titres against H1N1v [ Time Frame: 11 - 15 months ] [ Designated as safety issue: No ]
    The percentage of children with microneutralisation (MN) titres ≥ 1:40, 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix.


Secondary Outcome Measures:
  • Immunogenicity of trivalent seasonal influenza vaccine [ Time Frame: 12 - 16 months ] [ Designated as safety issue: No ]
    The percentage of children who seroconvert and have a post-vaccination MN titre ≥1:40 or HI titre ≥1:32 (H1N1 strain) or who were seropositive at pre-vaccination and have a 4- fold increase in titre, following one dose of a non-adjuvanted seasonal trivalent influenza vaccine, 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix

  • Reactogenicity of trivalent seasonal influenza vaccine [ Time Frame: 12 - 16 months ] [ Designated as safety issue: No ]
    The percentage of children experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following one dose of a non-adjuvanted seasonal trivalent influenza vaccine 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix.

  • Persistence of antibody titres to H1N1v [ Time Frame: 11 - 15 months ] [ Designated as safety issue: No ]
    The percentage of children with HI titre ≥ 1: 32 and the geometric mean HI and MN titres in children 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix.

  • Long-term safety monitoring of Pandemrix and Celvapan [ Time Frame: 11 - 15 months ] [ Designated as safety issue: No ]
    Specific adverse events (influenza-like illnesses (ILI), hospitalisations, febrile convulsions, autoimmunity and adverse events of special interest (AESIs) will be assessed in all participants.

  • T cell Responses [ Time Frame: 11 - 15 months ] [ Designated as safety issue: No ]
    The T cell responses to internal influenza antigens and haemagglutinin (pandemic H1).

  • Genetics [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The identification of genes differentially expressed in response to vaccination with the seasonal influenza strain.


Estimated Enrollment: 560
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Baxter H1N1 vaccine
Previously received 2 dose schedule of Baxter H1N1 vaccine
Drug: Seasonal Flu vaccine
1 dose of seasonal trivalent flu vaccine (Fluarix)
GSK H1N1 vaccine
Previously received 2 dose schedule of GSK H1N1 vaccine
Drug: Seasonal Flu vaccine
1 dose of seasonal trivalent flu vaccine (Fluarix)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We intend to recruit all interested participants who completed the original NIHR funded study (NCT00980850)(1) (n=937) into groups 1 & 2 outlined in table one above. It is anticipated that approximately 66% of these participants are likely to take part in this follow-on study; therefore the study population for groups 1 & 2 is likely to be approximately 560 children. As the option of only having a blood sample taken at visit 1 will be made available to participants in this study, there will be two cohorts of participants: the 'persistence' cohort (consenting to the baseline blood test alone) and the 'booster' cohort (consenting to the baseline blood test, seasonal influenza vaccine and post-immunisation blood test).

Criteria

Inclusion Criteria:

The participants must have completed the original NIHR funded study (NCT00980850)(1) comparing Celvapan with Pandemrix at one of the study sites participating in this follow-on study.

A parent/legal guardian has given written informed consent after the nature of the study has been explained.

Willingness to either

  1. undertake a blood test at visit 1 ('persistence' cohort)
  2. complete all study procedures ('booster' cohort)

Exclusion Criteria:

Participant(s) in original study (NCT00980850)(1) who had a suspected unexpected serious adverse reaction (SUSAR).

Participants in the original study (NCT00980850)(1) who did not receive two doses of H1N1 influenza vaccine.

Participants in original study (NCT00980850)(1) who received a third dose of H1N1 influenza vaccine due to an inadequate response to two doses.

History of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza 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 enrolment.

Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrolment.

Previous receipt of, or intent to immunize with, any other seasonal influenza vaccine(s) throughout the 2010/2011 influenza season.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239537

Locations
United Kingdom
Bristol Children's Vaccine Centre, University of Bristol
Bristol, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
St George's Vaccine Institute, University of London
London, United Kingdom
Oxford Vaccine Group, University of Oxford
Oxford, United Kingdom, OX3 7LJ
University of Southampton Wellcome Trust Clinical Research Facility
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
University of Oxford
Investigators
Study Director: Andrew Pollard, MRCP, PhD Oxford Vaccine Group, University of Oxford
Principal Investigator: Liz Miller, FRCPath, DSc Health Protection Agency, United Kingdom
Principal Investigator: Paul Heath, FRCPCH St George's 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: Matthew Snape, FRCPCH, MD Oxford Vaccine Group
Principal Investigator: Richard Tomlinson Royal Devon and Exeter NHS Foundation Trust
  More Information

Publications:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01239537     History of Changes
Other Study ID Numbers: 2010/03
Study First Received: November 10, 2010
Last Updated: May 7, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014