Swine Flu (Influenza A H1N1) Follow on Vaccine Study

NCT01239537 | Completed DMC

• 1 other identifier: 2010/03
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Persistence of MICRONEUTRALISING antibody titres against H1N1v

  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.

  11 - 15 months

Secondary Outcomes (6)

• Immunogenicity of trivalent seasonal influenza vaccine

  12 - 16 months

• Reactogenicity of trivalent seasonal influenza vaccine

  12 - 16 months

• Persistence of antibody titres to H1N1v

  11 - 15 months

• Long-term safety monitoring of Pandemrix and Celvapan

  11 - 15 months

• T cell Responses

  11 - 15 months

Study Arms (2)

Baxter H1N1 vaccine

Previously received 2 dose schedule of Baxter H1N1 vaccine

Drug: Seasonal Flu vaccine

GSK H1N1 vaccine

Previously received 2 dose schedule of GSK H1N1 vaccine

Drug: Seasonal Flu vaccine

Interventions

Seasonal Flu vaccine DRUG

1 dose of seasonal trivalent flu vaccine (Fluarix)

Baxter H1N1 vaccine; GSK H1N1 vaccine

Eligibility Criteria

• Age: 17 Months - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (5)

Bristol Children's Vaccine Centre, University of Bristol

Bristol, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

St George's Vaccine Institute, University of London

London, United Kingdom

Location

Oxford Vaccine Group, University of Oxford

Oxford, OX3 7LJ, United Kingdom

Location

University of Southampton Wellcome Trust Clinical Research Facility

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (3)

• de Whalley P, Walker W, Snape MD, Oeser C, Casey M, Moulsdale P, Harrill C, Andrews N, Hoschler K, Thompson B, Jones C, Chalk J, Kerridge S, Tomlinson R, Heath PT, Finn A, Faust S, Miller E, Pollard AJ. A 1-year follow-on study from a randomised, head-to-head, multicentre, open-label study of two pandemic influenza vaccines in children. Health Technol Assess. 2011 Dec;15(45):v-vi, xi-xiii, 1-128. doi: 10.3310/hta15450.

  PMID: 22257497 BACKGROUND

• Walker WT, de Whalley P, Andrews N, Oeser C, Casey M, Michaelis L, Hoschler K, Harrill C, Moulsdale P, Thompson B, Jones C, Chalk J, Kerridge S, John TM, Okike I, Ladhani S, Tomlinson R, Heath PT, Miller E, Faust SN, Snape MD, Finn A, Pollard AJ. H1N1 antibody persistence 1 year after immunization with an adjuvanted or whole-virion pandemic vaccine and immunogenicity and reactogenicity of subsequent seasonal influenza vaccine: a multicenter follow-on study. Clin Infect Dis. 2012 Mar 1;54(5):661-9. doi: 10.1093/cid/cir905. Epub 2012 Jan 19.

  PMID: 22267719 BACKGROUND

• Lambe T, Spencer AJ, Mullarkey CE, Antrobus RD, Yu LM, de Whalley P, Thompson BA, Jones C, Chalk J, Kerridge S, Hill AV, Snape MD, Pollard AJ, Gilbert SC. T-cell responses in children to internal influenza antigens, 1 year after immunization with pandemic H1N1 influenza vaccine, and response to revaccination with seasonal trivalent-inactivated influenza vaccine. Pediatr Infect Dis J. 2012 Jun;31(6):e86-91. doi: 10.1097/INF.0b013e318255e443.

  PMID: 22466328 RESULT

MeSH Terms

Conditions

Influenza, Human

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 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

GB (5)