E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (for primary immunization against meningococcal serogroup C and booster immunization against Haemophilus influenzae type b diseases of healthy children aged 12-18 months) |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammation of the brain and infection of the blood |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028911 |
E.1.2 | Term | Neisseria meningitidis infection NOS |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070120 |
E.1.2 | Term | Haemophilus influenzae test positive |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018953 |
E.1.2 | Term | Haemophilus influenzae meningitis |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10069533 |
E.1.2 | Term | Haemophilus influenzae type b immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070124 |
E.1.2 | Term | Neisseria meningitidis test positive |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018952 |
E.1.2 | Term | Haemophilus influenzae infection |
E.1.2 | System Organ Class | 100000004862 |
|
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 |
One month after vaccination, to demonstrate the non-inferiority of the meningococcal serogroup C and Hib responses induced by GSK Biologicals’ Hib-MenC conjugate vaccine, compared to separately administered MenC-CRM197 and Hiberix™ (with Priorix™ co-administered in each group), when given as a single dose to toddlers 12-18 months of age primed with routine infant vaccines including Hib, but no meningococcal serogroup C vaccine, in terms of percentage of subjects with SBA-MenC titre >= 1:8 and percentage of subjects with Anti-PRP concentration >= 0.15 µg/mL. |
|
E.2.2 | Secondary objectives of the trial |
Prior to and one month after vaccination:
• To evaluate the anti-PRP, anti-PSC and SBA-MenC immune response induced by GSK Biologicals’ Hib-MenC conjugate vaccine versus separately administered Hiberix™ and MenC-CRM197 (with Priorix™ co-administered in each group), when given as one dose to toddlers 12-18 months of age primed with routine infant vaccines including Hib, but no meningococcal serogroup C vaccine.
• To evaluate the safety and reactogenicity of Hib-MenC compared to Hiberix™ and MenC-CRM197 vaccines administered separately, when both groups receive a separate concomitant injection of Priorix™.
One, two, three, four and five years after vaccination:
• To evaluate the long-term persistence of the immune response induced by Hib-MenC compared to separately administered Hiberix™ and MenC-CRM197, when both groups receive a separate concomitant injection of Priorix™. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 12 and 18 months of age at the time of 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.
• Previously completed routine childhood vaccinations to the best of his/her parents’/guardians knowledge.
• Having completed primary vaccination with two doses of Hib-OMP containing vaccine OR three doses of DTPa/Hib containing vaccine at least 6 months before the study start. |
|
E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or planned use during the study period
• Chronic or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination
• Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before and ending 30 days after vaccination
• Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose
• Previous administration of a booster dose of Hib vaccine
• Previous vaccination against measles, mumps, rubella
• History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases
• Known exposure to measles, mumps or rubella within 30 days prior to the start of the study
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including 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 neurological disorders or more than one episode of febrile convulsion
• Acute disease at the time of enrolment
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
For the long-term persistence phase:
• Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines
• History of H. influenzae type b, meningococcal serogroup C diseases |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• SBA-MenC titre
• Anti-PRP concentration |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination |
|
E.5.2 | Secondary end point(s) |
• SBA-MenC titres and Anti-PRP concentrations
• Anti-PSC concentrations
• Occurrence of solicited local and general adverse events
• Occurrence of unsolicited non-serious adverse events
• Occurrence of any serious adverse events |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Prior to, one month after vaccination and 1, 2, 3, 4, and 5 years after vaccination
• Prior to, one month after vaccination and 1, 2 and 3 years after vaccination
• During the solicited follow-up period (Day 0 - Day 3) after vac-cination
• Within 30 days after vaccination
• Throughout the study |
|
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 |
Immunogenicity, reactogenicity |
|
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |