| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| One dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 months |
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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 |
Co-administration of MenACWY-TT and Infanrix hexa
In subjects of the MenACWY-TT + Infanrix hexa and MenACWY-TT groups:
To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine co-administered with combined DTPa-HBV-IPV/Hib vaccine to the MenACWY-TT conjugate vaccine given alone in terms of serum bactericidal antibodies (rSBA) for N. meningitidis serogroups A, C, W-135, and Y.
In subjects of the MenACWY-TT + Infanrix hexa and Infanrix hexa groups:
To demonstrate the non-inferiority of the combined DTPa-HBV-IPV/Hib vaccine co-administered with MenACWY-TT conjugate vaccine to DTPa-HBV-IPV/Hib vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), percentages of subjects with antibody concentrations to PRP >= 1.0µg/ml and to HBsAg >= 10mIU/ml.
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| E.2.2 | Secondary objectives of the trial |
evaluate the non-inferiority of Infanrix hexa co-administered with MenACWY-TT to Infanrix hexa given alone
compare the immunogenicity of MenACWY-TT co-administered with Infanrix hexa to MenACWY-TT given alone
compare the immunogenicity of MenACWY-TT given 1 month after Infanrix hexa to MenACWY-TT given 1 month before Infanrix hexa
compare the immunogenicity of Infanrix hexa given one month after MenACWY-TT to Infanrix hexa given one month before MenACWY-TT
compare the immunogenicity of MenACWY-TT given alone to Meningitec for N. meningitidis serogroup C
compare the immunogenicity of MenACWY-TT co-administered with the Infanrix hexa to Meningitec vaccine for N. meningitidis serogroup C
evaluate the safety and reactogenicity of each vaccine in terms of the occurrence of solicited and unsolicited symptoms
describe SAEs and specific AEs occurring up to 6 months after meningococcal vaccination |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
All subjects must satisfy the following criteria at study entry:
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
•Written informed consent obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination. This will be recorded in the subject’s eCRF.
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| E.4 | Principal exclusion criteria |
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean >= 0.5 mg/kg/day prednisone or equivalent. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
•Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.
•Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.
•Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b.
•History of meningococcal disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
•History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
•Major congenital defects or serious chronic illness.
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C/ Rectal temperature <38°C / Axillary temperature <37.5°C / Tympanic temperature on oral setting <37.5°C)
•Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
1 month after first vaccine dose:
In subjects of the MenACWY-TT + Infanrix hexa and MenACWY-TT groups:
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers >= 1:8
In subjects of the MenACWY-TT + Infanrix hexa and Infanrix hexa groups:
•Anti-PT, anti-FHA, anti-PRN concentrations and anti-HBs and anti-PRP seroprotection (defined as anti-HBs titres >= 10 mIU/ml and anti-PRP concentrations >= 1.0 µg/ml)
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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 | 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 | 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) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| 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) | Yes |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 102 |
| 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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| 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 | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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