E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects without known medical conditions will be vaccinated against N. menigitidis serogroup C. Active prevention of menigococcal C disease caused by Neisseria menigitidis |
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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 demonstrate non-inferiority, 10 days after the booster vaccination, of the memory antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (study group 2) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (study group 1), as measured by bactericidal assay using rabbit complement (rBCA). |
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E.2.2 | Secondary objectives of the trial |
-Compare the memory response (% responders) in group 3 with the memory response in study group 1. -Compare the memory response group 1, with the antibody response elicited after 1 dose given in the 2nd year of life. -Evaluate the response 1 month after 1 dose of Menjugate at 2 or 6 months of age. Compare the response 1 month after 1 dose of Menjugate at either 2 or 6 months of age with the antibody response 1 month after 2 doses at 2 and 4 months of age. -Evaluate the persistence of the response in study groups 1 to 3 and the persistence of antibody response after 2 doses at 2 and 4 months of age, before the administration of the booster at ≥8 to ≤10, 12-16, and at 24 months of age after booster vaccination. -Evaluate the memory response after 1 dose of Menjugate at either 2 or 6 months of age plus a booster dose in the 2nd year of life. -Evaluate the imm. response of hexavalent vaccine components with priority on H.influenzae type B, when concomitantly given with Menjugate. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy infants (7 to 11 weeks of age), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
for whom the parents/legal guardians have given written informed consent after the nature of the study has been explained;
who are available for all the visits scheduled in the study;
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E.4 | Principal exclusion criteria |
Whose parents/legal guardians are unwilling or unable to give written informed consent to their child’s participation in the study;
Who previously received Meningococcal C vaccine of any kind;
Who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, history of microbiologically proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping;
Who have had household contact with and/or intimate exposure to an individual with microbiologically proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days;
Who have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 60 days prior to enrolment, through to 30 days following any study vaccine administration; except for the vaccination against Tuberculosis which is allowed to be given to the subjects in the Polish sites since this is a legally required infant vaccination in Poland given to the child at birth and except for the Hepatitis B vaccination given in Poland at birth as well and except for vaccination with DTaP-IPV-HBV/Hib, which as routine infant vaccination is allowed to be given concomitantly to the study medication as indicated in the time and events table above.
Who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
Who received prior vaccination with DTaP-IPV-HBV/Hib or any of the components (before the age of 2 months), unless the exception for Hepatitis B in Poland applies;
Who have experienced fever (rectal temperature ≥ 38.5°C) within the past 3 days or are suffering from a present acute infectious disease;
Who have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 10 days;
Who have any present or suspected serious chronic disease such as cardiac or autoimmune disease or insulin dependent diabetes;
Who have leukemia, lymphomas, neoplasm;
With a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy, including use of corticosteroids known to be associated with suppression of hypothalamic-pituitary-adrenal (HPA) axis (i.e., systemic corticosteroids [eg 1 mg/kg/day of prednisone or its equivalent] or chronic use of inhaled high-potency corticosteroids [budesonide 800 µg per day or fluticasone 750 µg per day]). Those subjects who are known to have asthma and did conclude a systemic corticosteroid therapy above the mentioned limit at least 30 days previous to entering the study shall not be excluded.
Who have received blood, blood products or a parenteral immunoglobulin preparation; With a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
Who have any other serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
Who have a history of seizure disorder;
With an genetic anomaly (known cytogenic disorders) e.g., Down’s syndrome;
Who with their parents/legal guardians are planning to leave the area of the study site before the end of the study period;
With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Subjects that have a history of serologically or clinically confirmed HIV, Hepatitis B or Hepatitis C infection; |
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate non-inferiority, 10 days after the booster vaccination, of the memory antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (study group 2) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (study group 1), as measured by bactericidal assay using rabbit complement (rBCA) |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | 28 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 28 |