Clinical trial NCT00861744: Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
Official title: A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rubella
Mumps
Measles
Measles-Mumps-Rubella Vaccine
Keywords: Measles, Mumps, Rubella, Varicella Vaccine
Children
Immunogenicity
Safety
Humans
Combined Vaccine
Vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 1259
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.

The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.


Eligibility criteria: Inclusion Criteria:

* Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
* Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
* Written informed consent obtained from the parent/guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* 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 (pharmaceutical product or device).
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
* Previous vaccination against measles, mumps, rubella and/or varicella.
* Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
* History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
* Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Hypersensitivity to latex
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures, including febrile seizures.
* Acute disease at the time of enrolment.
* Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.

Primary outcomes:
measure: Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
timeFrame: At Day 42 after administration of a dose of Priorix vaccine.
measure: Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
timeFrame: At Day 42 after administration of a dose of Priorix vaccine.
measure: Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
timeFrame: At Day 42 after administration of a dose of Priorix vaccine.
Secondary outcomes:
measure: Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
timeFrame: At Day 42 after administration of a dose of Varivax vaccine.
measure: Anti-measles Virus Antibody Concentrations
timeFrame: At Day 42 after administration of a dose of Priorix vaccine.
measure: Anti-mumps Virus Antibody Concentrations
timeFrame: At Day 42 after administration of a dose of Priorix vaccine.
measure: Anti-rubella Virus Antibody Concentrations
timeFrame: At Day 42 after administration of a dose of Priorix vaccine.
measure: Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
timeFrame: At Day 42 after vaccination
measure: Anti-varicella Antibody Concentrations.
timeFrame: At Day 42 after administration of a dose of Varivax vaccine.
measure: Anti-hepatitis A Virus Antibody Concentrations.
timeFrame: At Day 42 after administration of a dose of Havrix vaccine.
measure: Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
timeFrame: At Day 42 after administration of a dose of Havrix vaccine.
measure: Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
timeFrame: At Day 0 before vaccination
measure: Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At 1 year post-vaccination
measure: Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
timeFrame: At 2 years post-vaccination
measure: Anti-measles Virus Antibody Concentrations
timeFrame: At 2 years post-vaccination
measure: Anti-measles Virus Antibody Concentrations
timeFrame: At 1 year post-vaccination
measure: Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Febrile Convulsions
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
timeFrame: At 1 year post-vaccination
measure: Number of Subjects Reporting Other Rash.
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
timeFrame: At 1 year post-vaccination
measure: Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
timeFrame: At 1 year post-vaccination
measure: Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
timeFrame: At 2 years post-vaccination
measure: Anti-rubella Virus Antibody Concentrations
timeFrame: At 1 year post-vaccination
measure: Anti-rubella Virus Antibody Concentrations
timeFrame: At 2 years post-vaccination
measure: Number of Subjects Reporting Fever.
timeFrame: During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
measure: Number of Subjects With Solicited Local Symptoms.
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Reporting Medically Attended Visit (MAEs)
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
timeFrame: During the 43-day (Days 0-42) post-vaccination period
measure: Number of Subjects With Solicited General Symptoms.
timeFrame: During the 15-day (Days 0-14) post-vaccination period
measure: Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
timeFrame: From Day 0 to Day 180 after vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Day 180 after vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAEs).
timeFrame: From Day 180 to Day 730 after vaccination
measure: Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
timeFrame: From Day 0 to Day 180 after vaccination
measure: Anti-mumps Virus Antibody Titers (Unenhanced PRN)
timeFrame: At 1 year post-vaccination
measure: Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
timeFrame: At 1 year post-vaccination
measure: Anti-mumps Virus Antibody Titers (Unenhanced PRN)
timeFrame: At 2 years post-vaccination
measure: Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
timeFrame: At 2 years post-vaccination
measure: Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
timeFrame: At 1 year post-vaccination
measure: Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
timeFrame: At 1 year post-vaccination
measure: Anti-mumps Virus Antibody Concentrations (PPD ELISA)
timeFrame: At 2 years post-vaccination
measure: Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
timeFrame: At 2 years post-vaccination
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: GSK Investigational Site
state: Alabama
city: Conway
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Downey
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: Santa Ana
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Altamonte Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Dalton
country: United States
facility: GSK Investigational Site
state: Georgia
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: DeKalb
country: United States
facility: GSK Investigational Site
state: Illinois
city: Arkansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Great Falls
country: United States
facility: GSK Investigational Site
state: Montana
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: Utica
country: United States
facility: GSK Investigational Site
state: New York
city: Cary
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Gresham
country: United States
facility: GSK Investigational Site
state: Oregon
city: East Norriton
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Rydal
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: GSK Investigational Site
state: Texas
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Provo
country: United States
facility: GSK Investigational Site
state: Utah
city: Saint George
country: United States
facility: GSK Investigational Site
state: Utah
city: Springville
country: United States
facility: GSK Investigational Site
state: Utah
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Virginia Beach
country: United States
facility: GSK Investigational Site
state: Virginia
city: Huntington
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Bayamon
country: Puerto Rico
facility: GSK Investigational Site
city: San Germán
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Mufson MA, Diaz C, Leonardi M, Harrison CJ, Grogg S, Carbayo A, Carlo-Torres S, JeanFreau R, Quintero-Del-Rio A, Bautista G, Povey M, Da Costa C, Nicholson O, Innis BL. Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months. J Pediatric Infect Dis Soc. 2015 Dec;4(4):339-48. doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.
citation: Berry AA, Abu-Elyazeed R, Diaz-Perez C, Mufson MA, Harrison CJ, Leonardi M, Twiggs JD, Peltier C, Grogg S, Carbayo A, Shapiro S, Povey M, Baccarini C, Innis BL, Henry O. Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin. Hum Vaccin Immunother. 2017 Jul 3;13(7):1516-1522. doi: 10.1080/21645515.2017.1309486. Epub 2017 May 8.