| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Active immunization of healthy children during their second year of life against measles, mumps, rubella and varicella diseases. |
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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 |
Primary objective
To assess the immunogenicity of a 4-week interval and a 12-month interval between two doses of MeMuRu-OKA 42-56 days after the second dose for all antigens.
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| E.2.2 | Secondary objectives of the trial |
To assess immunogenicity for measles, mumps, rubella and varicella:
- 42-56 days post-dose1 in Group MeMuRu-OKA/12 months.
- 28-30 days post-dose1 in Group MeMuRu-OKA/4 weeks
To assess immunogenicity for measles, mumps and rubella:
- 28-30 days post-dose1 and 42-56 days post-dose2 in Group Priorix.
To assess antibody persistence for measles, mumps, rubella and varicella:
- one year post-dose1 in Group MeMuRu-OKA/12 months.
- one year post-dose2 in Group MeMuRu-OKA/4 weeks.
To assess antibody persistence for measles, mumps and rubella:
- one year post-dose2 in Group Priorix
To assess the safety and reactogenicity of the study vaccines.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| 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 subject between 11-13 months of age (i.e. from 11-month birthday until the day before the 14-month birthday) at the time of the first vaccination.
Note: Subjects to be enrolled in Germany should receive two doses of the vaccine during the second year of life according to the local recommendation. To comply with this recommendation, the age of subjects at the time of the first vaccination in Germany is suggested to be from 11-month to 12.5-month of age.
Written informed consent obtained from the parent or guardian of the subject (or from both parents as required in The Netherlands).
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 |
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 vaccine(s) 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 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 from 30 days prior to each vaccination until 42-56 days after each vaccination.
N. meningitidis type C conjugate vaccine is allowed to be given up to seven days - Previous vaccination against against measles, mumps, rubella and/or varicella.
- History of measles, mumps, rubella and/or varicella/zoster diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial.
- 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.
- Residence in the same household as the following persons:
New-born infants (0-4 weeks of age).
Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
Persons with known immunodeficiency.
- 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., axillary temperature <37.5°C / rectal temperature <38°C.
- Rectal temperature ≥38.0ºC or axillary temperature ≥37.5ºC at the time of vaccination.
- Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Seroconversion (SC) rates for measles, mumps, rubella and varicella in Group MeMuRu-OKA 4/weeks and in Group MeMuRu-OKA 12/months approximately 42-56 days after the second dose. |
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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 |
| immunogenicity; mumps and varicella virus identification by PCR from clinical samples collected |
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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 | No |
| 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 | Yes |
| E.8.1.7.1 | Other trial design description |
| Partially blind according to group assignment |
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| 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 | Yes |
| E.8.2.3.1 | Comparator description |
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| 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
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For data handling and reporting purposes, the study is divided into two phases (1 & 2). The study is therefore designed to have two conclusion visits (i.e., the last study visit of phase 1 and of phase 2).
The end of the trial is the last study visit of phase 2. |
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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 | 14 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 14 |
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