E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Measles, mumps, rubella and varicella diseases |
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E.1.1.1 | Medical condition in easily understood language |
Measles, mumps, rubella and chickenpox diseases |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 OKAnew WS to MeMuRu OKA in terms of seroconversion rate to the measles, mumps, rubella, varicella components after the first dose |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the immunogenicity of all components of the study vaccine after each dose.
•To evaluate the safety and reactogenicity of the study vaccines.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•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 between, and including, 11 and 21 months of age (e.g. from age 11 months until the day before age 22 months) at the time of the first vaccination.
•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 healthy 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, 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.)
•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 prior to until 42 days after each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza† or diphtheria/tetanus-containing vaccines which can be administered up to eight days before each study vaccine dose.
† Inactivated H1N1 influenza vaccine can be given at ANY time to subjects in Taiwan only.
•Previous vaccination 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 within 30 days prior to study start.
•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(s), including systemic hypersensitivity to neomycin.
•Major congenital defects or serious chronic illness.
•History of any neurologic 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 >= 38°C or axillary temperature >= 37.5°C at the time of vaccination.
•Residence in the same household as a high risk person e.g.:
-New-born infants (0-4 weeks of age)
-Pregnant women who have a negative history of chickenpox
-Persons with known immunodeficiency
•Hypersensitivity to latex.
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E.5 End points |
E.5.1 | Primary end point(s) |
Seroconversion rates for measles (ELISA), mumps (ELISA), rubella (ELISA) and varicella (IFA) approximately 42-56 days after the first dose |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Measles, mumps, rubella and varicella seroconversion rates 42-56 days after the second dose. Measles, mumps, rubella and varicella antibody titres 42-56 days after the first and second dose. Occurrence of any and grade 3 solicited local symptoms (injection site redness, pain and swelling) within four days after each vaccination (Day 0-3). Occurrence of any and grade 3 solicited general symptoms within 43 days after each vaccination (Day 0-42) in terms of fever (defined as axillary temperature >=37.5°C/rectal temperature >=38.0°C), rash, any sign of meningitis including febrile convulsion and parotitis. Occurrence, intensity and relationship to vaccination of unsolicited symptoms within 43 days after each vaccination (Day 0-42). Occurrence of serious adverse events from the first study vaccine dose up to study end
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0, Day 3, Day 43-57, Day 86-114 and Day 129-171
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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 | No |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |