Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children 6 months to 12 years of age. - Head-to-head comparison of two H1N1 swine influenza vaccines in childre

• Conditions: Prophylaxis of influenza in an officially declared pandemic situation.; MedDRA version: 12.0Level: LLTClassification code 10059429Term: Influenza immunisation; MedDRA version: 12.0Level: LLTClassification code 10059637Term: Influenza antibody test; MedDRA version: 12.0Level: LLTClassification code 10059642Term: Influenza antibody test positive; MedDRA version: 12.0Level: LLTClassification code 10059643Term: Influenza antibody test negative; MedDRA version: 12.0Level: LLTClassification code 10060063Term: Influenza serology; MedDRA version: 12.0Level: LLTClassification code 10060078Term: Influenza serology positive; MedDRA version: 12.0Level: LLTClassification code 10060079Term: Influenza serology negative; MedDRA version: 12.0Level: LLTClassification code 10022000Term: Influenza; MedDRA version: 12.0Level: LLTClassification code 10022002Term: Influenza A virus infection

• Registration Number: EUCTR2009-014719-11-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

The participant must satisfy all the following criteria to be eligible for the study:
• baby or child aged between 6 months to 12 years of age (i.e. to day before 13th birthday).
• for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
• available for all the visits scheduled in the study
• willingness to complete all study procedures
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

The potential participants may not enter the study if ANY of the following apply:
• History of any vaccine against novel influenza A strain H1N1 (based on verbal confirmation from parent/guardian);
• Previous laboratory confirmed case of novel influenza A strain H1N1 or treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 (n.b. a child commenced on treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 whose treatment was stopped following negative microbiological tests for H1N1 on nasals swabs would be allowed to enrol in the study].
• History of severe allergic reaction after previous vaccinations or hypersensitivity to any H1N1 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;
• Intent to immunize with any other vaccine(s) against novel influenza A strain H1N1 throughout the study period;
• 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.

Temporary Exclusion Criteria
• Participants who have experienced fever (>38.0°C) within the previous 24 hours
• Participants receiving another immunisation within 3 days prior to enrolment (21 days for any live vaccine), or planning to receive another vaccine within 7 days of enrolment

Study & Design

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