Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

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.

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.

Study Overview

• Status: Completed
• Conditions: Measles; Rubella; Mumps; Measles-Mumps-Rubella Vaccine
• Intervention / Treatment: Biological: GSK Biological's investigational vaccine 209762; Biological: Varivax®; Biological: Havrix®; Biological: Prevnar®; Biological: M-M-R® II (Merck and Co)

• Study Type: Interventional
• Enrollment (Actual): 1259
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamon, Puerto Rico, 00959
    • GSK Investigational Site
  • San Germán, Puerto Rico, 00683
    • GSK Investigational Site
  • San Juan, Puerto Rico, 00936-5067
    • GSK Investigational Site
• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35401
      • GSK Investigational Site
  • Arkansas
    • Conway, Arkansas, United States, 72034
      • GSK Investigational Site
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Anaheim, California, United States, 92804
      • GSK Investigational Site
    • Downey, California, United States, 90241
      • GSK Investigational Site
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
    • Paramount, California, United States, 90723
      • GSK Investigational Site
    • Santa Ana, California, United States, 92701-4607
      • GSK Investigational Site
    • West Covina, California, United States, 91790
      • GSK Investigational Site
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • GSK Investigational Site
  • Georgia
    • Dalton, Georgia, United States, 30721
      • GSK Investigational Site
    • Marietta, Georgia, United States, 30062
      • GSK Investigational Site
  • Idaho
    • Nampa, Idaho, United States, 83686
      • GSK Investigational Site
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • GSK Investigational Site
  • Kansas
    • Arkansas City, Kansas, United States, 67005
      • GSK Investigational Site
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • GSK Investigational Site
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • GSK Investigational Site
    • Metairie, Louisiana, United States, 70006
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21021
      • GSK Investigational Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02724
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • GSK Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89015
      • GSK Investigational Site
  • New York
    • Utica, New York, United States, 13502
      • GSK Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45406
      • GSK Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • GSK Investigational Site
  • Oregon
    • Gresham, Oregon, United States, 97030
      • GSK Investigational Site
  • Pennsylvania
    • East Norriton, Pennsylvania, United States, 19401
      • GSK Investigational Site
    • Rydal, Pennsylvania, United States, 19046
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • GSK Investigational Site
  • Texas
    • Corpus Christi, Texas, United States, 78411
      • GSK Investigational Site
  • Utah
    • Layton, Utah, United States, 84041
      • GSK Investigational Site
    • Provo, Utah, United States, 84604
      • GSK Investigational Site
    • Saint George, Utah, United States, 84790
      • GSK Investigational Site
    • Springville, Utah, United States, 84663
      • GSK Investigational Site
    • West Jordan, Utah, United States, 84088
      • GSK Investigational Site
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • GSK Investigational Site
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Priorix 1 Group; Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Biological: GSK Biological's investigational vaccine 209762; Subcutaneous injection, one dose; Biological: Varivax®; Subcutaneous injection, one dose; Biological: Havrix®; Intramuscular injection, one dose; Biological: Prevnar®; Intramuscular injection, one dose
Experimental: Priorix 2 Group; Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Biological: GSK Biological's investigational vaccine 209762; Subcutaneous injection, one dose; Biological: Varivax®; Subcutaneous injection, one dose; Biological: Havrix®; Intramuscular injection, one dose; Biological: Prevnar®; Intramuscular injection, one dose
Experimental: Priorix 3 Group; Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Biological: GSK Biological's investigational vaccine 209762; Subcutaneous injection, one dose; Biological: Varivax®; Subcutaneous injection, one dose; Biological: Havrix®; Intramuscular injection, one dose; Biological: Prevnar®; Intramuscular injection, one dose
Active Comparator: MMR-II Group; Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Biological: Varivax®; Subcutaneous injection, one dose; Biological: Havrix®; Intramuscular injection, one dose; Biological: Prevnar®; Intramuscular injection, one dose; Biological: M-M-R® II (Merck and Co); Subcutaneous injection, one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.	Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.	At Day 42 after administration of a dose of Priorix vaccine.
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.	Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.	At Day 42 after administration of a dose of Priorix vaccine.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.	Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).	At Day 42 after administration of a dose of Priorix vaccine.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.	Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).	At Day 42 after administration of a dose of Varivax vaccine.
Anti-measles Virus Antibody Concentrations	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.	At Day 42 after administration of a dose of Priorix vaccine.
Anti-mumps Virus Antibody Concentrations	Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.	At Day 42 after administration of a dose of Priorix vaccine.
Anti-rubella Virus Antibody Concentrations	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.	At Day 42 after administration of a dose of Priorix vaccine.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.	At Day 42 after vaccination
Anti-varicella Antibody Concentrations.	Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.	At Day 42 after administration of a dose of Varivax vaccine.
Anti-hepatitis A Virus Antibody Concentrations.	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.	At Day 42 after administration of a dose of Havrix vaccine.
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.	Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).	At Day 42 after administration of a dose of Havrix vaccine.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.	At Day 0 before vaccination
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value	Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).	At 1 year post-vaccination
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value	Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).	At 2 years post-vaccination
Anti-measles Virus Antibody Concentrations	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.	At 2 years post-vaccination
Anti-measles Virus Antibody Concentrations	Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.	At 1 year post-vaccination
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.		During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Febrile Convulsions	Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.	During the 43-day (Days 0-42) post-vaccination period
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))	Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.	At 1 year post-vaccination
Number of Subjects Reporting Other Rash.	Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature	During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)	Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.	At 1 year post-vaccination
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.	Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.	At 1 year post-vaccination
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.	Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).	At 2 years post-vaccination
Anti-rubella Virus Antibody Concentrations	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.	At 1 year post-vaccination
Anti-rubella Virus Antibody Concentrations	Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.	At 2 years post-vaccination
Number of Subjects Reporting Fever.	fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.	During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
Number of Subjects With Solicited Local Symptoms.	Solicited local symptoms assessed were pain, redness and swelling.	During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Medically Attended Visit (MAEs)	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.	During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Unsolicited Adverse Events (AEs).	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.	Swelling with accompanying general symptoms	During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Solicited General Symptoms.	Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.	During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).	NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.	From Day 0 to Day 180 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.	From Day 0 to Day 180 after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.	From Day 180 to Day 730 after vaccination
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.		From Day 0 to Day 180 after vaccination
Anti-mumps Virus Antibody Titers (Unenhanced PRN)	Antibody titers were expressed as Geometric Mean Titer (GMT).	At 1 year post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)	Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).	At 1 year post-vaccination
Anti-mumps Virus Antibody Titers (Unenhanced PRN)	Antibody concentrations are expressed as Geometric Mean Titer (GMT).	At 2 years post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)	Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).	At 2 years post-vaccination
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)	Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.	At 1 year post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)	Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)	At 1 year post-vaccination
Anti-mumps Virus Antibody Concentrations (PPD ELISA)	Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.	At 2 years post-vaccination
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)	Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)	At 2 years post-vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2009
• Primary Completion (Actual): July 21, 2010
• Study Completion (Actual): June 18, 2012

Study Registration Dates

• First Submitted: March 12, 2009
• First Submitted That Met QC Criteria: March 12, 2009
• First Posted (Estimate): March 13, 2009

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Humans; Safety; Children; Vaccines; Immunogenicity; Combined Vaccine; Measles, Mumps, Rubella, Varicella Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Salivary Gland Diseases; Togaviridae Infections; Rubivirus Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Measles; Rubella; Mumps; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 111870; 2011-005860-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Clinical Study Report
   Information identifier: 111870
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 111870
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 111870
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 111870
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 111870
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 111870
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: 111870
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register