Immunogenicity and safety study of GSK Biologicals’ combined measles-mumps-rubella vaccine in subjects seven years of age and older (209762).

Conditions: Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy subjects, 7 years of age and older).
MedDRA version: 17.1Level: LLTClassification code 10069547Term: Mumps immunizationSystem Organ Class: 100000004865
MedDRA version: 17.1Level: LLTClassification code 10039276Term: Rubella with unspecified complicationsSystem Organ Class: 100000004862
MedDRA version: 17.1Level: LLTClassification code 10069545Term: Measles immunizationSystem Organ Class: 100000004865
MedDRA version: 17.1Level: LLTClassification code 10039274Term: Rubella with other specified complicationSystem Organ Class: 100000004862
MedDRA version: 17.1Level: LLTClassification code 10069564Term: Rubella immunizationSystem Organ Class: 100000004865
MedDRA version: 17.1Level: LLTClassification code 10028274Term: Mumps with other specified complicationSystem Organ Class: 100000004862
MedDRA version: 17.1Level: LLTClassification code 10027021Term: Measles without mention of complicationSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]
MedDRA version: 17.1Level: LLTClassification code 10027020Term: Measles with unspecified complicationSystem Organ Class: 100000004862

Registration Number: EUCTR2011-003672-36-EE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 334
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 666
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • 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.;Secondary Objective: • 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.<br>• 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.<br>• To assess safety and reactogenicity of INV_MMR vaccine and COM_MMR vaccine.<br>;Primary end point(s): Evaluation of immunogenicity of the study vaccines in terms of antibody concentration.;Timepoint(s) of evaluation of this end point: At Day 42

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Evaluation of immunogenicity of the study vaccines in terms of seroresponse<br>2. A minimum 4-fold rise in anti-measles, anti-mumps and anti-rubella virus antibody concentration.<br>3. Occurrence of solicited local symptoms<br>4. Occurrence of solicited general symptoms<br>5. Occurrence of unsolicited adverse events (AEs)<br>6. Occurrence of pre-specified AEs<br>7. Occurrence of Serious Adverse Events (SAEs);Timepoint(s) of evaluation of this end point: 1. At Day 42<br>2. At Day 42<br>3. From Day 0 to Day 3 after vaccination<br>4. From Day 0 to Day 42 after vaccination<br>5. From Day 0 to Day 42 after vaccination<br>6. From Day 0 through study end (Day 180)<br>7. From Day 0 through study end (Day 180)