| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Two-dose primary immunization course in healthy infants in the first year of life with a booster dose at 11 months of age against Haemophilus influenzae type b and meningococcal serogroup C diseases. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 6.1 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10021881 |
|
| 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 |
| Primary vaccination At one month after the second dose Post vacc II, at 6 months of age To demonstrate the non-inferiority of the meningococcal serogroup C immune response induced by GSK Biologicals Hib-MenC conjugate vaccine given concomitantly with InfanrixTM penta when administered as a 2-dose primary vaccination course 3-5 month schedule , compared to NeisVac-CTM co-administered with InfanrixTM hexa, in terms of -Percentage of subjects with SBA-MenC titre ge 1 8. To demonstrate the non-inferiority of the Hib immune response induced by GSK Biologicals Hib-MenC conjugate vaccine given concomitantly with InfanrixTM penta when administered as a 2-dose primary vaccination course 3-5 month schedule , compared to NeisVac-CTM co-administered with InfanrixTM hexa, in terms of Percentage of subjects with anti-PRP concentration ge 0.15 g/ml. |
|
| E.2.2 | Secondary objectives of the trial |
| Primary vaccination At one month after the second dose Post vacc II, at 6 months of age To evaluate the immunogenicity of Hib-MenC when co- administered with InfanrixTM penta compared to NeisVac-CTM co-administered with InfanrixTM hexa in terms of -Anti- PRP -SBA-MenCTM; Anti-PSC except anti-PRP concentration ge 0.15 g/ml and SBA-MenC titre ge 1 8 as already in the co-primary objectives To evaluate the immunogenicity of InfanrixTM; penta when co-administered with Hib-MenC compared to InfanrixTM hexa when co-administered with NeisVac-CTM in terms of anti-HBs. To evaluate the safety and reactogenicity of Hib-MenC given concomitantly with InfanrixTM penta compared to NeisVac-CTM when co-administered with InfanrixTM hexa. Persistence Prior to the administration of a booster dose Pre boost, at 11 months of age |
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
| 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 healthy male or female subject, between and including, 6 and 12 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject prior to the study entry. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Born after a gestation period between and including 36 and 42 weeks. |
|
| E.4 | Principal exclusion criteria |
| Use of any investigational or non-registered product drug or vaccine other than the study vaccine s since birth or planned use during the study period. Chronic administration defined as more than 14 days of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ge 0.5 mg/kg/day. Inhaled and topical steroids are allowed. Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG. Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease History of Haemophilus influenzae type b and /or meningococcal serogroup C disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus HIV infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. 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. Rectal temperature 38 C. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Additional specific criteria for the booster phase of the study to be checked at Visit 4 Previous booster vaccination with a Hib vaccine. Previous booster vaccination with a serogroup C meningococcal vaccine. Previous booster vaccination with a DTP containing vaccine. Previous booster vaccination with a IPV containing vaccine. Previous booster vaccination with a Hep B containing vaccine. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| One month after the second dose Post vacc II, at 6 months of age , in all subjects SBA-MenC titre ge 1 8 seroprotection . anti-PRP concentration ge 0.15 g/ml seroprotection . |
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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 | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| 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) | 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) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
|
| 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
| |
| 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 | 3 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
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