| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy male and female children between 15 months and 6 years of age who previously received an MMR vaccine will receive one dose of MMR + V or MMRV. A second dose of varicella vaccine will be given to all subjects. |
|
| 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 demonstrate the non-inferiority of MeMuRu-OKA vaccine to Priorix and
Varilrix vaccines administered as separate injections in terms of varicella
seroconversion rate 42-56 days after the first vaccination in initially seronegative
subjects.
• To demonstrate the non-inferiority of MeMuRu-OKA vaccine to Priorix and
Varilrix vaccines administered as separate injections in terms of measles, mumps
and rubella geometric mean titers (GMTs) 42-56 days after the first vaccination. |
|
| E.2.2 | Secondary objectives of the trial |
• To assess the immunogenicity of the study vaccines in terms of measles, mumps and rubella seropositivity rates 42-56 days after the first vaccination.
• To assess the immunogenicity of the study vaccines in terms of varicella seroconversion rate 42-56 days after the second vaccination in initially seronegative subjects pre-dose 1.
• To assess the immunogenicity of the study vaccines in terms of varicella GMTs 42-56 days after each vaccination.
• To assess the reactogenicity and safety of the study vaccines.
|
|
| 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 they and 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 child between and including, 15 months and 6 years of age at the time of the vaccination.
• Children who previously received one dose of MMR vaccine at least 6 weeks before entering the study.
• Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
|
|
| E.4 | Principal exclusion criteria |
• Subjects who already received a second dose of MMR vaccine.
• 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, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the study vaccine dose until 42-56 days after vaccination.
• Previous vaccination against varicella.
• Known history of a measles, mumps, rubella and/or varicella infection.
• Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the study start.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• Any known anaphylactic reaction from previous administration of MMR-containing vaccine. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including obvious allergic reactions to neomycin, egg proteins.
• Major congenital defects or serious chronic illness.
• History of any neurological 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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F)
• Rectal temperature greater than or equal to 38°C or axillary temperature greater than or equal to 37.5°C at the time of vaccination.
• Residence in the same household as a high risk person during the study period e.g.:
- New-born infants (0-4 weeks of age)
- Pregnant women who have a negative history of chickenpox
- Persons with known immunodeficiency.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
• Varicella seroconversion rate, 42-56 days after the first vaccination of the study.
• Measles, mumps and rubella GMT ratios, 42-56 days after the first vaccination of 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 | 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 |
|
| 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| 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) | Yes |
| 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.8.5 | 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
|
| End of trial is the last study visit, i.e. 43-56 days after second vaccination |
|
| 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 | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
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