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, 7 years of age and older). |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069547 |
E.1.2 | Term | Mumps immunization |
E.1.2 | System Organ Class | 100000004865 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039276 |
E.1.2 | Term | Rubella with unspecified complications |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069545 |
E.1.2 | Term | Measles immunization |
E.1.2 | System Organ Class | 100000004865 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039274 |
E.1.2 | Term | Rubella with other specified complication |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069564 |
E.1.2 | Term | Rubella immunization |
E.1.2 | System Organ Class | 100000004865 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028274 |
E.1.2 | Term | Mumps with other specified complication |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027021 |
E.1.2 | Term | Measles without mention of complication |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027020 |
E.1.2 | Term | Measles with unspecified complication |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
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.1.3 | 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 in terms of geometric mean concentrations (GMCs) for anti-measles, anti-mumps and anti-rubella
antibodies at Day42. |
|
E.2.2 | Secondary objectives of the trial |
• To demonstrate the non-inferiority of INV_MMR vaccine to COM_MMR
vaccine, in terms of seroresponse rates to measles, mumps and rubella
viruses at Day 42.
• To assess the percentage of subjects who achieve a minimum 4-fold rise in anti measles, anti mumps or anti rubella virus antibody concentrations at Day 42.
• To assess safety and reactogenicity of INV_MMR vaccine and COM_MMR vaccine. |
|
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 Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Male or female subjects 7 years of age or older and born after December 31, 1956*. *The only exception to this is health care workers born before 1957 without other evidence of immunity to mumps for which one dose of a live mumps virus vaccine is recommended; therefore this population is eligible for enrollment in this study.
• For all children 7-17 years of age:
-Written documentation of prior receipt of 1 dose of MMR vaccine administered on or after the first birthday.
• For all adults 18 years of age and older:
-Prior receipt (written or verbal history) of at least one dose of MMR vaccine.
-Birth in the US.
• Written informed consent obtained from the subject or from the
parent(s)/LAR(s) of the subject (assent will be obtained from subjects
who are still legally minors in line with local rules and regulations).
• Subjects in stable health as determined by investigator's physical
examination and assessment of subjects' medical history.
• Female subjects of non-childbearing potential may be enrolled in the
study.
-Non-childbearing potential is defined as pre-menarche, current tubal
ligation, hysterectomy, or ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject
-Has agreed to be abstinent or practiced adequate contraception during the entire period starting 30 days prior to vaccination(s) until 3 months after receipt of the study vaccination and
-Has a negative pregnancy test on the day of vaccination. |
|
E.4 | Principal exclusion criteria |
• Child in care.
• For all children 7-17 years of age:
-Previous receipt of more than 1 dose of a measles-containing vaccine.
• Use of any investigational or non-registered product other than the study vaccine(s), during the period starting 30 days preceding the day of
study vaccination, (i.e. 30 days prior to Day 0) or planned use during the entire study period.
• Receipt of any measles, mumps or rubella-containing vaccine during the period starting 42 days before the day of study vaccination (i.e. 42
days prior to Day 0).
• Chronic administration (defined as 14 or more consecutive days) of immunosuppressants or other immune-modifying drugs during the
period starting 180 days before study vaccination or any planned administration of 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 prior to study vaccination through the
immunogenicity evaluation at Visit 2 or Visit 3 (for one-dose or two-dose cohort, respectively).
• Planned administration/ administration of any live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination and ending at Visit 2. Any inactivated vaccine required in the age group and inactivated influenza vaccine may be given at any time, including the day of study vaccination. (Inactivated vaccines must be administered at a different location than the study vaccine). Live intranasal influenza vaccine should not be given during the period starting 30 days prior to study vaccination and ending at Visit 2, except for the day of study vaccination.
• 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, or rubella disease.
• Known exposure to measles, mumps, or rubella, during the period starting 30 days before study start (i.e. 30 days prior to Day 0).
• 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 hypersensitivity to neomycin, latex or gelatin.
• Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms.
• Acute disease at the time of enrollment.
• Alcohol or drug abuse or history of any substance abuse.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions during the entire study period.
• 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of immunogenicity of the study vaccines in terms of antibody
concentration. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Evaluation of immunogenicity of the study vaccines in terms of
seroresponse
2. A minimum 4-fold rise in anti-measles, anti-mumps and anti-rubella
virus antibody concentration.
3. Occurrence of solicited local symptoms
4. Occurrence of solicited general symptoms
5. Occurrence of unsolicited adverse events (AEs)
6. Occurrence of pre-specified AEs
7. Occurrence of Serious Adverse Events (SAEs) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. At Day 42
2. At Day 42
3. From Day 0 to Day 3 after vaccination
4. From Day 0 to Day 42 after vaccination
5. From Day 0 to Day 42 after vaccination
6. From Day 0 through study end (Day 180)
7. From Day 0 through study end (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 | No |
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 |
|
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 | Yes |
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 | 2 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | No |
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 |
|
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 | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |