Trial record 17 of 105 for:    "Measles"

Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older

This study is not yet open for participant recruitment.
Verified April 2014 by GlaxoSmithKline
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02058563
First received: February 6, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine(M-M-R®II), which is approved for use in the US.


Condition Intervention Phase
Rubella
Mumps
Measles
Biological: Priorix®
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Seroresponse of INV_MMR vaccine as compared to COM_MMR vaccine [ Time Frame: 42 days after the last study vaccination (either Day 42 or Day 84) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity of the INV_MMR vaccine as compared to the COM_MMR vaccine in terms of antibody concentrations [ Time Frame: 42 days after the last study vaccination (either Day 42 or Day 84) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms [ Time Frame: From Day 0 to Day 3 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms [ Time Frame: From Day 0 to Day 42 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events (AEs) [ Time Frame: From Day 0 to Day 42 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of pre-specified AEs [ Time Frame: From Day 0 through study end (Day 180 or Day 222) ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From Day 0 through study end (Day 180 or Day 222) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INV_MMR
Subjects will receive either 1 or 2 doses of GSK Biologicals' trivalent Measles, Mumps, and Rubella Virus Vaccine (Priorix®) depending on the number of documented doses received prior to enrollment in this study
Biological: Priorix®
1 dose or 2 doses administered as a subcutaneous (SC) injection as one dose or 2 doses depending on the number of documented doses received prior to enrollment in this study
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
1 dose or 2 doses administered SC depending on the number of documented doses received prior to enrollment in this study
Active Comparator: COM_MMR
Subjects will receive either 1 or 2 doses Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine depending on the number of documented doses received prior to enrollment in this study
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
1 dose or 2 doses administered SC depending on the number of documented doses received prior to enrollment in this study

Detailed Description:

This study will evaluate the immunogenicity of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) in contrast to the US standard of care (M-M-R®II, Merck and Company, referred to as COM_MMR) when both are used as a second dose in subjects 7 years of age and older. In this study, the INV_MMR vaccine may be administered as a second dose to persons with either a history or formal documentation of one dose immunization with any measles- containing vaccine. In addition, subjects with either no history of vaccination or no documented history of vaccination who require 2-dose MMR vaccination will receive 2 doses of MMR approximately 42 days apart. This study is intended to support licensure of GSK's MMR vaccine in the US.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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 agrees 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(s) and has a negative pregnancy test on the day of vaccination.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s), during the period starting 30 days preceding the day of first 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 first study vaccination (i.e. 42 days prior to Day 0).
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days before the first 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 before the day of first 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 42 days prior to the first study vaccination and ending 42 days after the last study vaccination (either at Visit 2 or at Visit 3). Live intranasal influenza vaccine and any inactivated vaccine required in the age group may be given at any time, including 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.
  • Active 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02058563

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Parexel
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02058563     History of Changes
Other Study ID Numbers: 115231, 2011-003672-36
Study First Received: February 6, 2014
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Measles, mumps and rubella diseases
Safety
Immunogenicity

Additional relevant MeSH terms:
Measles
Mumps
Parotitis
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014