E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects without known medicial conditions will be vaccinated against Neisseria meningitidis serogroup C. Active prevention of meningococcal C disease caused by Neisseria meningitidis serogroup C
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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 establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with Menjugate®, as determined by meningococcal C specific B-cell ELISpot assay.
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E.2.2 | Secondary objectives of the trial |
To establish how long these B cells persist in the blood, and whether the plasma cell response is different following the first and third Menjugate® vaccination.
To determine the immune response to Neisseria meningitidis serogroup C, as measured by rBCA, 26-34 days after the third immunisation with Menjugate®.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. healthy infants aged 8-11 weeks; 2. available for the visits scheduled in the study; 3. in good health as determined by: - medical history - clinical judgment of the investigator - physical examination check performed by a physician; 4. whose parents can give written informed consent for the infant to be enrolled in the study. The infant’s parents must be willing for the infant to receive the full primary immunisation course. |
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E.4 | Principal exclusion criteria |
1. Whose parents have not given or are unwilling or unable to give written informed consent to their child’s participation in the study;
2. Known hypersensitivity to any vaccines contained within the routine immunisation schedule;
3. Unacceptable concurrent illnesses or conditions - infants: a. with a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; b. with a genetic anomaly, e.g. Down’s syndrome; c. with any immunodeficiency, including use of systemic corticosteroids; d. who have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days; e. born at less than 36 weeks gestation; f. weighing less than 2.5 kg at birth; g. with previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease; h. with a known bleeding diathesis, or any condition associated with a prolonged bleeding time;
4. Prohibited prior or concomitant medicationsa. a. Previous immunization with Meningococcal C Conjugate vaccine or any other elements of the routine primary immunisation schedule (excluding BCG given at birth or Hepatitis B given at birth if mother is HBsAg positive); b. Receipt of immunoglobulin; c. Receipt of any blood products; d. Antibiotic or antiviral therapy within the previous 14 days prior to visits including a blood draw;
5. Previous participation in this trial, current participation in another trial or participation in another trial within the last thirty days: a. Participation in any other clinical trial either currently or in the previous month; b. Inability to adhere to the protocol, including plans to move from the area;
6. Temporary Exclusion Criteria Any infant with axillary temperature of ≥ 38.0°C or any presence of any acute systemic illness on the day of immunisation.
7. Other With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with Menjugate®, as determined by meningococcal C specific B-cell ELISpot assay. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Characterise immune response, specifically B-cell response after first and third dose of Menjugate |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |