E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Influenza infections |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059429 |
E.1.2 | Term | Influenza immunisation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. Reactogenicity of trivalent seasonal influenza vaccine To compare 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.
2. Immunogenicity of trivalent seasonal influenza vaccine To compare 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.
3. Persistence of microneutralising antibody titres against H1N1v To compare the percentage of children with microneutralisation (MN) titres ≥ 1:40, 11-15 months after receiving a two-dose immunis |
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E.2.2 | Secondary objectives of the trial |
1. Persistence of antibody titres to H1N1v To compare the percentage of children with HI titre ≥ 1: 32 and the geometric mean HI and MN titres 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix.
2. Long-term safety monitoring of Pandemrix and Celvapan Specific adverse events (influenza-like illnesses (ILI) , hospitalisations, febrile convulsions, autoimmunity and adverse events of special interest (AESI’s )) will be assessed in all participants.
3. To store serum For future testing of the immunogenicity of trivalent seasonal influenza vaccine for H3N2 and B strains, 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix. Also, should a drifted H1N1 strain emerge next season, this would provide a valuable source of sera to assess cross protection.
4. T cell Responses To study the T cell responses to internal influenza antigens and haemagglutinin (pandemic H1)
5. Genetics To identify genes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Reactogenicity of trivalent seasonal influenza vaccine 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.
2. Persistence of MICRONEUTRALISING antibody titres against H1N1v 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
3. Immunogenicity of trivalent seasonal influenza vaccine 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunogenicity, reactogenicity |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is the date at which the processing of samples for the purposes of this study has been completed. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 2 |