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. - Swine Flu (Influenza A H1N1) follow on Vaccine Study Version 1

• Conditions: Prevention of Influenza infections; MedDRA version: 12.0Level: LLTClassification code 10059429Term: Influenza immunisation

• Registration Number: EUCTR2010-022817-24-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

All participants must satisfy all the following criteria to be eligible for the study:
• A parent/legal guardian has given written informed consent after the nature of the study has been explained;
• Willingness to complete visit 1.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified