Clinical trial NCT02058563: Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older
Official title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rubella
Mumps
Measles
Keywords: Measles, mumps and rubella diseases
Safety
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2014-02-10
Enrollment: 996
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 at least one dose immunization with any MMR vaccine. This study is intended to support licensure of GSK's MMR vaccine in the US.

Eligibility 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.
* 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.

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. Live intranasal influenza vaccine or 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).
* %

Primary outcomes:
measure: Anti-measles Virus Antibody Concentrations.
timeFrame: At Day 42
measure: Anti-mumps Virus Antibody Concentrations
timeFrame: At Day 42
measure: Anti-rubella Virus Antibody Concentrations.
timeFrame: At Day 42
Secondary outcomes:
measure: Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)
timeFrame: At Day 42
measure: Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).
timeFrame: At Day 42
measure: Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).
timeFrame: At Day 42
measure: Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.
timeFrame: At Day 42
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Reporting Fever
timeFrame: During the 43 days (Days 0-42) post-vaccination period.
measure: Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.
timeFrame: During the 43 days (Days 0-42) post-vaccination period.
measure: Number of Subjects Reporting Unsolicited AEs
timeFrame: During the 43 days (Days 0-42) post-vaccination period.
measure: Number of Subjects Reporting Solicited Rash Symptom
timeFrame: During the 43 days (Days 0-42) post-vaccination period.
measure: Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)
timeFrame: During the 43 days (Days 0-42) post-vaccination period.
measure: Number of Subjects Reporting NOCDs
timeFrame: Day 0 through the end of the study (Day 180)
measure: Number of Subjects Reporting Adverse Events Prompting ER Visits
timeFrame: Day 0 through the end of the study (Day 180)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Day 0 through the end of the study (Day 180)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Edina
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Dolny Kubin
country: Slovakia
facility: GSK Investigational Site
city: Dunajska Streda
country: Slovakia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Ruzomberok
country: Slovakia
facility: GSK Investigational Site
city: Zlate Moravce
country: Slovakia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Abu-Elyazeed R, Jennings W, Severance R, Noss M, Caplanusi A, Povey M, Henry O. Immunogenicity and safety of a second dose of a measles-mumps-rubella vaccine administered to healthy participants 7 years of age or older: A phase III, randomized study. Hum Vaccin Immunother. 2018;14(11):2624-2631. doi: 10.1080/21645515.2018.1489186. Epub 2018 Jul 12.