E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A/H1N1, Immunogenicity and Safety in Infants, Children and Adolescents, aged 6 months to 17 Years |
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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 | 10022000 |
E.1.2 | Term | Influenza |
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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 the immune response as determined by hemagglutination inhibition (HI) assay at two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years •To assess the safety of two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years
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E.2.2 | Secondary objectives of the trial |
•To assess the immune response as determined by microneutralization (MN) assay at two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years •To assess persistence of H1N1 influenza antibodies as determined by HI and MN assays 180 days or 360 days after the first vaccination with a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years •To assess the immune response to a booster vaccination as determined by HI and MN assays with a seasonal trivalent 2010/2011 influenza vaccine containing the A/H1N1/California/07/2009 strain in a subgroup of healthy infants, children and adolescents aged 6 months to 17 years
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subject’s parent(s) / legal guardian(s) provide(s) written informed consent (according to national law); •Subject provides written assent to the study according to age and capacity of understanding; •Subject is 9 to 17 years (Stratum A), 3 to 8 years (Stratum B), 12 to 35 months (Stratum C) or, 6 to 11 months of age (Stratum D) at the time of screening; •Subject was born at full term of pregnancy ( 37 weeks) with a birth weight 2 kg (Strata C and D); •Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the subject diary); •If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to the first vaccination and agrees to employ adequate birth control measures for the duration of the study; •Subject is generally healthy, as determined by the investigator’s clinical judgment through collection of medical history and the performance of a physical examination; •Subject is physically and mentally capable of participating in the study.
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E.4 | Principal exclusion criteria |
•Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological product or device during the course of this study; •Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen; •Subject has any inherited or acquired immune deficiency; •Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder ; •Subject has a history of testing positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV) No confirmatory testing for previous infection with these viruses will be conducted as part of this clinical study; •Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to: systemic or high dose inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs; •Subject has a history of severe allergic reactions or anaphylaxis; •Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating; •Subject has received a blood transfusion or immunoglobulins within 90 days of study entry; •Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study; •Subject has functional or surgical asplenia; •Subject has a known or suspected problem with alcohol or drug abuse; •Subject or one of subject’s parent(s) / legal guardian(s) is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, siblings, partner/spouse, parents) as well as employees of the investigator or site personnel conducting the study; •Subject is pregnant or lactating.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination as determined by HI assay (as per CPMP/BWP/214/96) The definitions of seroprotection and seroconversion for the HI assay are as follows: Seroprotection: A reciprocal HI titer ≥ 40 Seroconversion: A 4-fold or greater increase from baseline titer or a reciprocal HI titer ≥ 40 when there is no detectable titer at baseline •Antibody titer and antibody titer fold increase as compared to baseline in response to a H1N1 pandemic influenza vaccine as determined by HI assay 21 days after the second vaccination All serological analyses will be conducted for antibody activity against A/H1N1/California/07/2009. Serological testing may also be conducted for antibody activity against any closely related, newly emerging variants of this virus Safety: •Frequency and severity of injection site and systemic reactions occurring during the 7 days following each vaccination
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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 | Yes |
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 |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Phase I/II Study of a H1N1 Vaccine |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | Yes |
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 | No |
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 |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 duration of subject participation is approximately 382 days (12-month booster). The study may be prematurely terminated if SAE or other significant vaccine related side effects occur. In addition the Sponsor may stop the entire study for any medical reason at any time. |
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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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |