Swine Flu (Influenza A H1N1) Follow on Vaccine Study
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ClinicalTrials.gov Identifier: NCT01239537 |
Recruitment Status
:
Completed
First Posted
: November 11, 2010
Last Update Posted
: December 8, 2017
|
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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 or disease | Intervention/treatment |
---|---|
Influenza | Drug: Seasonal Flu vaccine |

Study Type : | Observational |
Estimated Enrollment : | 560 participants |
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. |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Group/Cohort | Intervention/treatment |
---|---|
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)
|
- Persistence of MICRONEUTRALISING antibody titres against H1N1v [ Time Frame: 11 - 15 months ]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.
- Immunogenicity of trivalent seasonal influenza vaccine [ Time Frame: 12 - 16 months ]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 ]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 ]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 ]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 ]The T cell responses to internal influenza antigens and haemagglutinin (pandemic H1).
- Genetics [ Time Frame: 1 month ]The identification of genes differentially expressed in response to vaccination with the seasonal influenza strain.

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Ages Eligible for Study: | 17 Months to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
- undertake a blood test at visit 1 ('persistence' cohort)
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239537
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 |
Study Director: | Andrew Pollard, MRCP, PhD | Oxford Vaccine Group, University of Oxford | |
Principal Investigator: | 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 |
Publications of Results:
Other Publications:
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT01239537 History of Changes |
Other Study ID Numbers: |
2010/03 |
First Posted: | November 11, 2010 Key Record Dates |
Last Update Posted: | December 8, 2017 |
Last Verified: | December 2017 |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |