E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The Novartis Meningococcal A, C, W-135 and Y Vaccine is intended for prevention of meningitidis and/or septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y. |
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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 the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a 2, 4-month course of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age To evaluate the safety and tolerability of Novartis MenACWY vaccine when given at 2 and 4 months of age concomitantly with a combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine (DTaP-Hib-IPV, Pediacel®) and a heptavalent PCV (Prevenar®) To evaluate the safety and tolerability of Novartis MenACWY vaccine when given with or without concomitant PCV at 12 months of age |
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E.2.2 | Secondary objectives of the trial |
To assess whether the frequency of Men ACWY serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a 2, 4-month course of MenACWY vaccine, predicts: -The concentration of (respectively) serogroup A, C, W-135 and Y specific IgG and memory B-cells at 12 months of age. -(respectively) serogroup A, C, W-135 and Y specific memory B-cells and IgG concentrations and hSBA titers 1 month after a booster dose of MenACWY administered at 12 months of age. -the rise from pre-booster levels in (respectively) serogroup A, C, W-135 and Y specific IgG, and memory B-cell concentration and hSBA titers 1 month after a booster dose of MenACWY administered at 12 months of age -the concentration of (respectively) serogroup A, C, W-135 and Y specific plasma cells and memory B-cells and specific IgG and hSBA titers in the week following a booster dose of MenACWY administered at 12 months of age.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.healthy infants aged 2 months (56 – 83 days old, inclusive) 2.available for the visits scheduled in the study; 3.mother available for blood draw at Visit 1; 4.in good health as determined by: -medical history -clinical judgment of the investigator -pre-vaccination check performed by a physician; 5.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 immunization 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. With known hypersensitivity to any vaccines contained within the routine immunization schedule 3. With unacceptable concurrent illnesses or conditions – e.g.: a. 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. a genetic anomaly, e.g. Down’s syndrome; c. any immunodeficiency, including use of systemic corticosteroids; d. born at less than 36 weeks gestation; e. weighing less than 2.5 kg at birth; f. 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; g.known bleeding diathesis, or any condition associated with a prolonged bleeding time; 4. Who have received any prohibited prior or concomitant medications - e.g.: a. any immunizations within the 30 days prior to enrollment, with the exception of BCG or hepatitis B; b. immunoglobulin; c. any blood products; 5. Participating in any other clinical trial either currently or in the previous month; 6. Unable to adhere to the protocol, including plans to move from the area; 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 assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a 2, 4-month course of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age. |
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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 | 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) | 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 | No |
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 | 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) | 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 | 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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The End of Trial corresponds to the last visit or the last phone contact to 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 | |
E.8.9.1 | In the Member State concerned months | 22 |
E.8.9.1 | In the Member State concerned days | |