E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Meningococcal serogroup C infection |
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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 |
Describe the characteristics of the antibody secreting cell (ASC) response generated in the circulation following immunization describing the changes occurring in ASC number and immunophenotype over time. |
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E.2.2 | Secondary objectives of the trial |
Assess the relationship between ASC number and serum and salivary antibody levels |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Written informed consent for the study to be performed according to the study schedule.-Adults between 18 and 40 years.-Available throughout the study period.-Ability to understand the written information provided. |
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E.4 | Principal exclusion criteria |
-Receipt of any vaccination or investigational agent within 50 days of enrolment to the study.-Chronic administration (defined as treatment for more than 14 days) of any immunosuppressant or immune modifying drug (topical or inhaled steroids will be excluded from this definition). -A history of meningococcal infection or contact with a proven index case within 60 days of enrolment to the study.-Pregnancy or plans to become pregnant during the study. -Breast feeding.-Any chronic cardiac, respiratory, gastrointestinal, renal, neurological or psychiatric condition.-Any confirmed or suspected immunodeficiency (congenital or acquired).-Administration of immunoglobulins or any other blood products within one-year of study enrolment or planned administration during the study period.-History of anaphylactic shock or allergic reaction to a previous vaccination or to any vaccine component.-Acute illness or fever during the three days preceding study enrolment-Lack of availability at any time during the study period.-Any other condition which, in the opinion of the clinical research fellow (EC), may interfere with the evaluation of the study objectives for any reason. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quantification of the number of antibody secreting cells generated in the blood following the intramuscular immunisation of 21 healthy adult volunteers |
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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 | No |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Status prior to vaccination |
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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.8.5 | 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 | Information not present in EudraCT |
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
|
Last visit of last enrolled trial participant. |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |