E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization of healthy children aged 10 to less than 18 years against A/California/7/2009 (H1N1)v-like influenza |
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MedDRA Classification |
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 |
To assess whether vaccination with monovalent A/California/7/2009 (H1N1)v-like vaccine (each treatment group) results in an immune response to the vaccine-homologous virus that meets or exceeds the CHMP guidance targets for pandemic vaccine seroconversion rate (SCR), rate of induction of vaccine-homologous reciprocal hemagglutination inhibition (HI) titers greater than or equal to 40 (potential seroprotection rate [SPR]) and geometric mean fold rise (GMFR) 21 days after the first dose of H1N1 vaccine in children 10 to < 18 years of age. |
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E.2.2 | Secondary objectives of the trial |
To describe the vaccine virus homologous and heterologous HI response to vaccination with 3 different formulations of the A/California/7/2009 (H1N1)v-like vaccine in terms of reciprocal geometric mean titer (GMT), seropositivity rate, SCR, SPR and GMFR. To describe the homologous and heterologous microneutralization (MN) antibody response to vaccination with 3 different formulations of the A/California/7/2009 (H1N1)v-like vaccine in terms of reciprocal GMT, seropositivity rate and vaccine response (VRR). To evaluate the safety and reactogenicity of the H1N1 candidate vaccines in terms of solicited adverse events (AEs), unsolicited AEs, medically attended AEs (MAEs), serious adverse events (SAEs), potential immune-mediated diseases (pIMDs) and clinical laboratory parameters.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female children 10 to less than 18 years of age at the time of the first vaccination. “Less than 18 years of age” implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol. Written informed consent obtained from the subject’s parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate. Good general health as established by medical history and clinical examination before entering into the study. Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments). Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol (e.g. collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to bring the study subject to scheduled visits) as documented by signature on the informed consent document (and, if appropriate, the informed assent document).
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E.4 | Principal exclusion criteria |
Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus. Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine. Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports. Presence of a temperature ≥ 38.0ºC by any route or method, or acute symptoms greater than “mild” severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. Diagnosed with cancer, or treatment for cancer, within 3 years. NOTE: Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). Receipt of systemic glucocorticoids (e.g., prednisone greater than or equal to 0.5 mg/kg/day, or greater than or equal to 10 mg/day [whichever is less] for more than 14 consecutive days) within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed. Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period. Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible. An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine. Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine). Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy. Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. Child in care.
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E.5 End points |
E.5.1 | Primary end point(s) |
Humoral immune response in terms of HI antibodies Vaccine virus-homologous responses as demonstrated by the HI antibody titers 21 days after the first dose of H1N1 vaccine (Day 21) Derived aggregate variables to evaluate the primary objective: SCR at Day 21 SPR at Day 21 GMFR at Day 21
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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 | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Unadjuvanted Q-Pan H1N1 vaccine (15 µg HA) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | No |
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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last visit of the last subject undergoing the trial |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |