| 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 subjects, 4 to 6 years of age). |
|
| E.1.1.1 | Medical condition in easily understood language |
| Measles, mumps and rubella |
|
| 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 | 18.0 |
| 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 | 18.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10059638 |
| E.1.2 | Term | Mumps antibody test |
| E.1.2 | System Organ Class | 10022891 - Investigations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10027015 |
| E.1.2 | Term | Measles like illness |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | HLT |
| E.1.2 | Classification code | 10039270 |
| E.1.2 | Term | Rubella viral infections |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| 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.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10027022 |
| E.1.2 | Term | Measles-like rash |
| E.1.2 | System Organ Class | 100000004858 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10039261 |
| E.1.2 | Term | Rubella immunity (confirmed) |
| E.1.2 | System Organ Class | 10022891 - Investigations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10028262 |
| E.1.2 | Term | Mumps like illness |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| 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 | 18.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10060066 |
| E.1.2 | Term | Measles antibody |
| E.1.2 | System Organ Class | 10022891 - Investigations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10039255 |
| E.1.2 | Term | Rubella antibodies not present |
| E.1.2 | System Organ Class | 10022891 - Investigations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | HLT |
| E.1.2 | Classification code | 10028268 |
| E.1.2 | Term | Mumps viral infections |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10039259 |
| E.1.2 | Term | Rubella antibody test |
| E.1.2 | System Organ Class | 10022891 - Investigations |
|
| 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 Inv_MMR vaccine to Com_MMR vaccine, when administered with VV and DTaP-IPV vaccines in terms of seroresponse rates to measles, mumps and rubella viruses at Day 42.
•To demonstrate the non-inferiority of Inv_MMR vaccine to Com_MMR vaccine, when administered with VV and DTaP-IPV vaccines in terms of antibody concentrations to measles, mumps and rubella viruses at Day 42.
•To demonstrate the non-inferiority of Inv_MMR vaccine to Com_MMR vaccine, when administered without VV and DTaP-IPV vaccines in terms of seroresponse rates to measles, mumps and rubella viruses at Day 42
•To demonstrate the non-inferiority of Inv_MMR vaccine to Com_MMR vaccine, when administered without VV and DTaP-IPV vaccines in terms of antibody concentrations to measles, mumps and rubella viruses at Day 42 |
|
| E.2.2 | Secondary objectives of the trial |
•To demonstrate the non-inferiority in terms of seroresponse rates and antibody concentrations to varicella zoster virus (VZV) at Day 42 when VV is given with Inv_MMR and DTaP-IPV vaccines as compared to when given with Com_MMR and DTaP-IPV vaccines
•To demonstrate the non-inferiority in terms of antibody booster response to Diphtheria (D), Tetanus (T), Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) when DTaP-IPV is given with Inv_MMR and VV as compared to when given with Com_MMR and VV
•To demonstrate the non-inferiority in terms of antibody titers to poliovirus types 1, 2 and 3 when DTaP-IPV is given with Inv_MMR vaccine and VV as compared to when given with Com_MMR and VV
•To demonstrate the non-inferiority in terms of anti-PT, anti-FHA and anti-PRN antibody levels when DTaP-IPV is given with Inv_MMR vaccine and VV as compared to when given with Com_MMR and VV
•To assess safety and reactogenicity of Inv_MMR and Com_MMR vaccines in each sub-cohort |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol
•Male or female subjects 4 to 6 years of age at the time of vaccination
•Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations)
•Subjects in stable health as determined by investigator’s physical examination and assessment of subjects’ medical history
•Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life
•For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:
-subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
-subjects received a first dose of VV in the second year of life
|
|
| E.4 | Principal exclusion criteria |
•Child in care
•Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period
•Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s
•Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
•History of measles, mumps, and/or rubella disease
•Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin 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) measured 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 according to the subject’s medical history
•Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:
•Previous vaccination with a second dose of varicella-containing vaccine
•Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination
•History of varicella/zoster disease
•Known exposure to varicella/zoster during the period starting 30 days prior to enrollment
•History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease
•Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life
•Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids
•Following a previous administration of DTP vaccine: temperature >= 40.6°C (>=105° F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine
•Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given with VV and DTaP-IPV vaccines in terms of antibody concentration.
Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given without VV and DTaP-IPV in terms of antibody concentration
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 42 days after vaccination (At Day 42) |
|
| E.5.2 | Secondary end point(s) |
- Immunogenicity with respect to VV in terms of antibody concentration.
- Immunogenicity with respect to the components of DTaP-IPV vaccine in terms of antibody concentration.
- Occurrence of solicited local symptoms.
- Occurrence of solicited general symptoms.
- Occurrence of Adverse events of specific interest.
- Occurrence serious adverse events. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Days 0-3, Day 42, Day 180 |
|
| 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) | 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 |
|
| 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 | 9 |
| 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 |
| Korea, Republic of |
| Taiwan |
| 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.8.9.2 | 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 | 12 |
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