| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life). |
|
| E.1.1.1 | Medical condition in easily understood language |
| Measles, mumps and rubella diseases |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10028257 |
| E.1.2 | Term | Mumps |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10021881 |
| E.1.2 | Term | Infections and infestations |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10039252 |
| E.1.2 | Term | Rubella |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10027011 |
| E.1.2 | Term | Measles |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| 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 of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates to MMR viruses at Day 42.
•To demonstrate non-inferiority of Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean concentrations (GMCs) for antibodies to MMR viruses at Day 42.
•To demonstrate an acceptable immune response of Inv_MMR vaccine in terms of seroresponse rates for MMR viruses at Day 42.
•To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of seroresponse rates for mumps virus (by Plaque Reduction Neutralization Test (PRNT)) at Day 42.
•To demonstrate non-inferiority of the Inv_MMR vaccine compared to pooled Com_MMR vaccine lots in terms of geometric mean titer (GMT) for antibodies to mumps virus (by PRNT) at Day 42. |
|
| E.2.2 | Secondary objectives of the trial |
•To assess the immunogenicity of Inv_MMR_Min and pooled Com_MMR vaccine in terms of seroresponse rates and GMCs for antibodies to measles, mumps and rubella viruses at Day 84 (post Dose 2) (in a sub-cohort of children enrolled in the US).
•To assess the immunogenicity of Inv_MMR_Med and pooled Com_MMR vaccine in terms of seroresponse rate and GMCs for antibodies to measles, mumps and rubella viruses at Day 84 (post Dose 2) (in a sub-cohort of children enrolled in the US).
•To assess the safety and reactogenicity of Inv_MMR_Min, Inv_MMR_Med, and Com_MMR when co-administered with Varivax, Havrix (to all children), and Prevnar 13 (only to children enrolled in the US). |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Male or female child between 12 and 15 months of age at the time of vaccination.
•The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.
•Written informed consent obtained from the parent(s)/LAR(s) of the child.
•Child is in stable health as determined by investigator’s clinical examination and assessment of child’s medical history.
For US children only:
•Child that previously received a 3-dose series of Prevnar 13 at least 60 days prior to study entry. |
|
| E.4 | Principal exclusion criteria |
•Child in care.
•Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination or planned use during the entire study period.
•Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
•Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
-Inhaled and topical steroids are allowed.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:
-Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
-Any age appropriate vaccine may be given starting at Visit 2 (or starting at Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.
•Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the US post-dose 2 sub-cohort.
•History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
•Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the first study vaccination.
•Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin.
•Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
•Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C/100.4°F by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
•Active untreated tuberculosis based on medical history.
•Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.
For US children only:
•A child that previously received a fourth dose of any pneumococcal conjugate vaccine. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity of the MMR vaccines:
•Seroresponse to measles, mumps and rubella viruses (by ELISA) and to mumps virus (by PRNT).
•Measles, mumps and rubella virus antibody concentrations (by ELISA) and mumps virus antibody titers (by PRNT). |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
Immunogenicity of the MMR vaccines post-dose 2 (US post-dose 2 sub-cohort). In terms of antibody concentration:
•Seroresponse to measles, mumps and rubella viruses (by ELISA).
•Measles, mumps and rubella virus antibody concentrations (by ELISA) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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, Prevention |
|
| 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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.8.2.4 | Number of treatment arms in the trial | 4 |
| 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 | 12 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 34 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Czech Republic |
| Finland |
| Malaysia |
| Spain |
| Thailand |
| United States |
|
| 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.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| 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 | 8 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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