Overview

Swine Flu (Influenza A H1N1) Follow on Vaccine Study

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Oxford
Treatments:
Vaccines
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.