Influenza Clinical Trial
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.
Verified date | December 2017 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 560 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Months to 14 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Bristol Children's Vaccine Centre, University of Bristol | Bristol | |
United Kingdom | Royal Devon and Exeter NHS Foundation Trust | Exeter | |
United Kingdom | St George's Vaccine Institute, University of London | London | |
United Kingdom | Oxford Vaccine Group, University of Oxford | Oxford | |
United Kingdom | University of Southampton Wellcome Trust Clinical Research Facility | Southampton |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
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. — View Citation
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Immunogenicity of trivalent seasonal influenza vaccine | 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 | 12 - 16 months | |
Secondary | Reactogenicity of trivalent seasonal influenza vaccine | 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. | 12 - 16 months | |
Secondary | Persistence of antibody titres to H1N1v | 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. | 11 - 15 months | |
Secondary | Long-term safety monitoring of Pandemrix and Celvapan | Specific adverse events (influenza-like illnesses (ILI), hospitalisations, febrile convulsions, autoimmunity and adverse events of special interest (AESIs) will be assessed in all participants. | 11 - 15 months | |
Secondary | T cell Responses | The T cell responses to internal influenza antigens and haemagglutinin (pandemic H1). | 11 - 15 months | |
Secondary | Genetics | The identification of genes differentially expressed in response to vaccination with the seasonal influenza strain. | 1 month |
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