Prophylaxis of influenza in an officially declared pandemic situation. MedDRA version: 12.0 Level: LLT Classification code 10059429 Term: Influenza immunisation MedDRA version: 12.0 Level: LLT Classification code 10059637 Term: Influenza antibody test MedDRA version: 12.0 Level: LLT Classification code 10059642 Term: Influenza antibody test positive MedDRA version: 12.0 Level: LLT Classification code 10059643 Term: Influenza antibody test negative MedDRA version: 12.0 Level: LLT Classificat
Conditions
Interventions
Trade Name: CELVAPAN
Product Name: Celvapan
Pharmaceutical Form: Suspension for injection
Other descriptive name: Whole virion influenza H1N1 vaccine, inactivated, containing antigen A/California/07/
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity • To compare the percentage of children aged 6 months to 12 years of age with a four fold rise in microneutralisation (MN) titres between the pre-vaccination sample and the sample taken three weeks after completion of a two dose course of the Baxter H1N1 vaccine and the GSK H1N1 vaccine. Reactogenicity • To compare the percentage of children aged 6 months to 12 years of age experiencing fever and local reactions within the seven days following each dose of the Baxter and GSK H1N1 vaccine ;Secondary Objective: • Compare % of children 6 months-12 years of age with Haemagglutination Inhibition (HAI) titres of = 1:32 three weeks after completion of a 2 dose course of Baxter or GSK H1N1 vaccine. • Compare % of children aged 6 months-12 years of age with four fold rise in HAI titres between pre-vaccination sample and sample taken three weeks after completion of a 2 dose course of Baxter or GSK H1N1 vaccine. • Geometric mean fold rise in HAI and MN titres from baseline to three weeks after 2 doses of Baxter or GSK H1N1 vaccine. • Geometric mean HAI and MN titres three weeks after 2 doses of Baxter or GSK H1N1 vaccine. • Assess % of children aged 6 months-12 years of age experiencing non-febrile systemic reactions within the 7 days following each dose of Baxter and GSK H1N1 vaccine • Investigate effect of genetic polymorphisms on immunogenicity and reactogenicity of the H1N1 vaccines.;Primary end point(s): Primary end points for the immunogenicity analysis will be defined as: • Percentage of subjects with a 4 fold rise in MN titre between the pre-vaccination sample and sample taken 3 weeks after the second dose Primary endpoints for reactogenicity analysis • Percentage of participants experiencing each of fever (= 38°C per axilla), local tenderness, local swelling or local erythema within the 7 days following each immunisation with the study vaccines | — |
Countries
United Kingdom
Outcome results
None listed