| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Booster vaccination against Streptococcus pneumoniae and active immunization against measles, mumps, rubella and varicella diseases in children during the second year of life. |
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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 the incidence of post-immunization rectal fever >39.0°C following a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with the first dose of MMRV vaccine in children 12 to 14 months of age. |
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| E.2.2 | Secondary objectives of the trial |
• To assess the safety and reactogenicity of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with the first or the second dose of MMRV vaccine at 12-14 months of age or 14-16 months of age respectively.
• To assess the immunogenicity of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with the first or the second dose of MMRV vaccine at 12-14 months of age or 14-16 months of age respectively.
• To assess the persistence of antibodies induced by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, 8-10 months after completion of the 3-dose immunization course in study 10PN-PD-DIT-001.
• To assess the immunogenicity, safety and reactogenicity of the first and the second dose of MMRV vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine between 12-16 months of age.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Male or female between, and including, ± 12-14 months of age at the time of first vaccination.
• Subjects who previously participated in the study 10PN-PD-DIT-001 and received at least one dose of 10-valent pneumococcal conjugate vaccine during the primary study.
• Subjects for whom 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 visit).
• 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.
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| E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine(s), or planned use during the entire study period (active phase and extended safety follow-up).
• 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 prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and ending 42-56 days after the last dose of vaccine(s).
• Administration of any additional pneumococcal vaccine since end of 10PN-PD-DIT-001 study.
• Previous vaccination against measles, mumps, rubella and/or varicella.
• History of or intercurrent measles, mumps, rubella and/or varicella/zoster diseases.
• Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.
• History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the active phase of the study.
• Any known anaphylactic reaction from previous administration of vaccine(s).
• 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 or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).
• Febrile illness defined as oral, axillary or tympanic temperature ≥37.5°C, rectal temperature ≥38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
• Residence in the same household as a high risk person for varicella (i.e. susceptible to develop complications due to shedding of live varicella vaccine virus by the vaccinee) during the study period e.g.: new-born infants (0-4 weeks of age), pregnant women with a negative history of chickenpox disease and without recorded vaccination against chickenpox and persons with known immunodeficiency.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| • To assess the incidence of post-immunization rectal fever >39.0°C following a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with the first dose of MMRV vaccine in children 12 to 14 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 | Information not present in EudraCT |
| 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) | 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 | 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 | 8 |
| 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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| Last subject, last contact. |
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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 | 11 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
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