| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (immunization against A/California/7/2009 (H1N1)v-like influenza) |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10073988 |
| E.1.2 | Term | Bird flu |
| E.1.2 | System Organ Class | 100000004862 |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10021433 |
| E.1.2 | Term | Immunization |
| E.1.2 | System Organ Class | 100000004865 |
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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 |
| To assess whether vaccination with 1 dose of 0.9 µg monovalent A/California/7/2009 (H1N1)v-like HA antigen produced in Quebec adjuvanted with AS03B and 1 dose of monovalent A/California/7/2009 (H1N1)v-like HA antigen produced in Dresden adjuvanted with AS03B; results in an immune response to the vaccine-homologous virus that meets or exceeds the U.S Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) and the European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) guidance targets for pandemic vaccine serocon-version rate (SCR), rate of induction of vaccine-homologous reciprocal hemagglutination inhibition (HI) titers >= 40 (potential seroprotection rate [SPR]) and geo-metric mean fold rise (GMFR) 21 days after vaccination in children 3 to < 10 years of age. |
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| E.2.2 | Secondary objectives of the trial |
•To demonstrate immunological equivalence of 0.9 µg HA antigen adjuvanted with AS03B manufactured in Quebec (Q-PAN H1N1) and 0.9 µg HA antigen adjuvanted with AS03B manufactured in Dresden (D-PAN H1N1), 21 days after vaccination.
•To describe immunogenicity (HI assay) to the vaccine homologous virus:
‒in subjects receiving 1.9 µg HA antigen adjuvanted with AS03B at Day 21 in terms of SCR, SPR and GMFR.
‒in each treatment group 21 days following vaccination in terms of reciprocal geometric mean titer (GMT) and seropositivity rate.
•To describe immunogenicity (HI assay) to the vaccine homologous virus in each treatment group at Day 182 in terms of reciprocal GMT, seropositivity rate, SCR, SPR and GMFR.
•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), and potential immune-mediated diseases (pIMDs). |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Male or pre-menarchal female children 3 to < 10 years of age at the time of the study vaccination. “Less than 10 years of age” implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of the study 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.
•Subjects and/or parent(s)/LAR who the investigator believes can and will comply with the requirements of the protocol 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 vaccination.
•Diagnosed with cancer, or treatment for cancer, within 3 years.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Receipt of systemic glucocorticoids within 1 month prior to study enrollment (day of study vaccination), 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.
•Administration of any licensed live-attenuated vaccine within 30 days before study vaccination or any licensed inactivated vaccine within 15 days before study vaccination.
•Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 21 phlebotomy.
•Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 21. 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 study vaccination, or planned use during the study period.
•Any known or suspected allergy to any constituent of influenza vaccines; 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 (A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts). |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Humoral immune response in terms of HI antibodies against vaccine virus- homologous A/California (H1N1) in terms of SCR*, SPR** and GMFR***.
*SCR is defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
**SPR is defined as the proportion of subjects with H1N1 reciprocal HI titers ≥40 against the tested vaccine virus.
***GMFR also known as the Seroconversion Factor (SCF) is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
- Vaccine-virus homologous antibody response as demonstrated by the HI antibody titers in terms of seropositivity, GMT, SCR, SPR, and GMFR
- Occurrence of specifically-solicited local and general signs and symptoms
- Occurrence of all unsolicited AEs
- Occurrence of MAEs, pIMDs, and SAEs |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Day 0, Day 7, Day 21, Day 42 and Day 182 |
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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 | Yes |
| 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 | Yes |
| 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 | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| 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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| E.8.9 Initial estimate of the duration of the trial |
| 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 | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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