Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age

Immunogenicity of GlaxoSmithKline Biologicals' MMRV Vaccine (208136) vs. ProQuad®, When Coadministered With Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12-14 Months of Age.

The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.

Study Overview

• Status: Completed
• Conditions: Measles; Rubella; Mumps; Varicella
• Intervention / Treatment: Biological: Priorix-Tetra™ (MMRV vaccine 208136); Biological: Havrix®; Biological: Prevnar®; Biological: ProQuad®

• Study Type: Interventional
• Enrollment (Actual): 1851
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35205
      • GSK Investigational Site
    • Tuscaloosa, Alabama, United States, 35401
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85003
      • GSK Investigational Site
  • Arkansas
    • Benton, Arkansas, United States, 72015
      • 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, 92805
      • GSK Investigational Site
    • Anaheim, California, United States, 92804
      • GSK Investigational Site
    • Buena Park, California, United States, 90620
      • GSK Investigational Site
    • Downey, California, United States, 90241
      • GSK Investigational Site
    • Fountain Valley, California, United States, 92708
      • GSK Investigational Site
    • Fremont, California, United States, 94538
      • GSK Investigational Site
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Hayward, California, United States, 94545
      • GSK Investigational Site
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
    • Lakewood, California, United States, 90711
      • GSK Investigational Site
    • Oakland, California, United States, 94611
      • GSK Investigational Site
    • Paramount, California, United States, 90723
      • GSK Investigational Site
    • Pleasanton, California, United States, 94588
      • GSK Investigational Site
    • San Francisco, California, United States, 94115
      • GSK Investigational Site
    • San Jose, California, United States, 95119
      • GSK Investigational Site
    • Torrance, California, United States, 90502
      • GSK Investigational Site
    • Vacaville, California, United States, 95688
      • GSK Investigational Site
    • West Covina, California, United States, 91790
      • GSK Investigational Site
  • Colorado
    • Centennial, Colorado, United States, 80112
      • GSK Investigational Site
    • Thornton, Colorado, United States, 80233
      • GSK Investigational Site
    • Westminster, Colorado, United States, 80234
      • GSK Investigational Site
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • GSK Investigational Site
    • Opa-locka, Florida, United States, 33054
      • GSK Investigational Site
    • Plantation, Florida, United States, 33324
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • GSK Investigational Site
  • Georgia
    • Carrollton, Georgia, United States, 30117
      • GSK Investigational Site
    • Dalton, Georgia, United States, 30721
      • GSK Investigational Site
    • Marietta, Georgia, United States, 30062
      • GSK Investigational Site
    • Tifton, Georgia, United States, 31794
      • GSK Investigational Site
    • Tucker, Georgia, United States, 30084
      • GSK Investigational Site
    • Woodstock, Georgia, United States, 30189
      • GSK Investigational Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • GSK Investigational Site
    • Honolulu, Hawaii, United States, 96819
      • GSK Investigational Site
  • Idaho
    • Nampa, Idaho, United States, 208 463 3126
      • GSK Investigational Site
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • GSK Investigational Site
  • Indiana
    • Fishers, Indiana, United States, 46038
      • GSK Investigational Site
    • Indianapolis, Indiana, United States, 46229
      • GSK Investigational Site
    • Lafayette, Indiana, United States, 47904
      • GSK Investigational Site
    • New Albany, Indiana, United States, 47150
      • GSK Investigational Site
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • GSK Investigational Site
    • Dubuque, Iowa, United States, 52002
      • GSK Investigational Site
    • Waukee, Iowa, United States, 50263
      • GSK Investigational Site
    • West Des Moines, Iowa, United States, 50266
      • GSK Investigational Site
  • Kansas
    • Arkansas City, Kansas, United States, 67005
      • GSK Investigational Site
    • Overland Park, Kansas, United States, 66215
      • GSK Investigational Site
    • Topeka, Kansas, United States, 66608
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67208
      • GSK Investigational Site
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • GSK Investigational Site
    • Lexington, Kentucky, United States, 40503
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40202
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40291
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40272
      • GSK Investigational Site
    • Owensboro, Kentucky, United States, 43202
      • GSK Investigational Site
    • Springfield, Kentucky, United States, 40069
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • GSK Investigational Site
    • Frederick, Maryland, United States, 21702
      • GSK Investigational Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02724
      • GSK Investigational Site
    • Woburn, Massachusetts, United States, 01801
      • GSK Investigational Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49008
      • GSK Investigational Site
    • Niles, Michigan, United States, 49120
      • GSK Investigational Site
    • Portage, Michigan, United States, 49024
      • GSK Investigational Site
    • Richland, Michigan, United States, 49083
      • GSK Investigational Site
    • Stevensville, Michigan, United States, 49127
      • GSK Investigational Site
  • Minnesota
    • Brainerd, Minnesota, United States, 56401
      • GSK Investigational Site
    • Saint Paul, Minnesota, United States, 55108
      • GSK Investigational Site
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • GSK Investigational Site
    • Columbia, Missouri, United States, 65203
      • GSK Investigational Site
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68131
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68132
      • GSK Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89015
      • GSK Investigational Site
    • Las Vegas, Nevada, United States, 89101
      • GSK Investigational Site
  • New Jersey
    • White House Station, New Jersey, United States, 08889
      • GSK Investigational Site
  • New York
    • Johnson City, New York, United States, 13790
      • GSK Investigational Site
    • Lake Success, New York, United States, 11040
      • GSK Investigational Site
    • Mineola, New York, United States, 11501
      • GSK Investigational Site
    • Rochester, New York, United States, 14618
      • GSK Investigational Site
    • Stony Brook, New York, United States, 11794
      • GSK Investigational Site
    • Syracuse, New York, United States, 13205
      • GSK Investigational Site
    • Utica, New York, United States, 13502
      • GSK Investigational Site
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • GSK Investigational Site
    • Cary, North Carolina, United States, 27518
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • GSK Investigational Site
    • Sylva, North Carolina, United States, 28779
      • GSK Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • GSK Investigational Site
    • Minot, North Dakota, United States, 58701
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45406
      • GSK Investigational Site
    • Fairfield, Ohio, United States, 45014
      • GSK Investigational Site
    • Huber Heights, Ohio, United States, 45424
      • GSK Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74107
      • GSK Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97402
      • GSK Investigational Site
    • Gresham, Oregon, United States, 97030
      • GSK Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • GSK Investigational Site
    • East Norriton, Pennsylvania, United States, 19401
      • GSK Investigational Site
    • Kittanning, Pennsylvania, United States, 16201
      • GSK Investigational Site
    • Latrobe, Pennsylvania, United States, 15650
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15236
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15217
      • GSK Investigational Site
    • Sellersville, Pennsylvania, United States, 18960
      • GSK Investigational Site
    • Uniontown, Pennsylvania, United States, 15401
      • GSK Investigational Site
    • Wexford, Pennsylvania, United States, 15090
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • GSK Investigational Site
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • GSK Investigational Site
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37203
      • GSK Investigational Site
  • Texas
    • Amarillo, Texas, United States, 79124
      • GSK Investigational Site
    • Bryan, Texas, United States, 77802
      • GSK Investigational Site
    • Corpus Christi, Texas, United States, 78411
      • GSK Investigational Site
    • Lubbock, Texas, United States, 79430
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78215
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78205
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78212
      • GSK Investigational Site
    • Sugar Land, Texas, United States, 77479
      • GSK Investigational Site
  • Utah
    • Layton, Utah, United States, 84041
      • GSK Investigational Site
    • Ogden, Utah, United States, 84405
      • GSK Investigational Site
    • Provo, Utah, United States, 84604
      • GSK Investigational Site
    • Saint George, Utah, United States, 84790
      • GSK Investigational Site
    • South Jordan, Utah, United States, 84095
      • GSK Investigational Site
    • West Jordan, Utah, United States, 84088
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • GSK Investigational Site
    • Charlottesville, Virginia, United States, 22902
      • GSK Investigational Site
    • Chesapeake, Virginia, United States, 23321
      • GSK Investigational Site
    • Midlothian, Virginia, United States, 23113
      • GSK Investigational Site
    • Vienna, Virginia, United States, 22180
      • GSK Investigational Site
    • Virginia Beach, Virginia, United States, 23454
      • GSK Investigational Site
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • GSK Investigational Site
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • GSK Investigational Site
    • Madison, Wisconsin, United States, 53792
      • GSK Investigational Site
    • Marshfield, Wisconsin, United States, 54449
      • 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.
• Male or female between 12 and 14 months of age at the time of first 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 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.

Exclusion Criteria:

• Use of any investigational or non-registered product 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.
• Chronic administration 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.
• 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 and/or varicella/zoster 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, including human immunodeficiency virus 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.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.

• Residence in the same household as the following persons:

  • New-born infants (0-4 weeks of age).
  • Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
  • Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
  • Persons with known immunodeficiency.
• Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
• Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
• Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Subjects received refrigerator-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation A) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180	Biological: Priorix-Tetra™ (MMRV vaccine 208136); One subcutaneous injection.; Biological: Havrix®; Two intramuscular injections.; Biological: Prevnar®; One intramuscular injection.
EXPERIMENTAL: Group B; Subjects received freezer-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation B) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180	Biological: Priorix-Tetra™ (MMRV vaccine 208136); One subcutaneous injection.; Biological: Havrix®; Two intramuscular injections.; Biological: Prevnar®; One intramuscular injection.
ACTIVE_COMPARATOR: Group C; Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180	Biological: Havrix®; Two intramuscular injections.; Biological: Prevnar®; One intramuscular injection.; Biological: ProQuad®; One subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)	Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.	At Day 42 after vaccination
Concentration of Antibodies to Varicella Virus (VZV)	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Mumps Virus	Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.	At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Measles Virus	Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.	At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Rubella Virus	Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.	At Day 42 after vaccination
Concentration of Antibodies to Hepatitis A Virus (HAV)	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Titers to Mumps Virus	Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.	At Day 42 after vaccination
Concentration of Antibodies to Measles Virus	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Concentration of Antibodies to Rubella Virus	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Number of Subjects With Vaccine Response to Havrix	Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.	At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value	Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).	At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value	Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).	At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value	Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).	At Day 42 after vaccination
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value	Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).	At Day 42 after vaccination
Number of Subjects Reporting Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling.	During the 4 day follow up period following vaccination
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination	Fever was measured rectally.	During the 15-day follow-up period following vaccination
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination	Fever was measured rectally.	During the 43-day follow-up period following vaccination
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash		During the 43-day follow-up period after vaccination
Number of Subjects Reporting Investigator-confirmed Varicella-like Rash		During the 43-day follow-up period after vaccination
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling		During the 43-day follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)	Unsolicited adverse event covers any adverse event 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. Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.	During the 43-day follow-up period after vaccination
Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits	New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.	For approximately 6 months (Day 0-180)
Number of Subjects Reporting Serious Adverse Events	Serious adverse events assessed include medical occurrences that result in death, is 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.	For approximately 6 months (Day 0-180)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Blatter MM, Klein NP, Shepard JS, Leonardi M, Shapiro S, Schear M, Mufson MA, Martin JM, Varman M, Grogg S, London A, Cambron P, Douha M, Nicholson O, da Costa C, Innis BL. Immunogenicity and safety of two tetravalent (measles, mumps, rubella, varicella) vaccines coadministered with hepatitis a and pneumococcal conjugate vaccines to children twelve to fourteen months of age. Pediatr Infect Dis J. 2012 Aug;31(8):e133-40. doi: 10.1097/INF.0b013e318259fc8a.

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: November 20, 2007
• Primary Completion (ACTUAL): February 24, 2009
• Study Completion (ACTUAL): March 17, 2009

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (ESTIMATE): December 21, 2007

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Humans; Safety; Children; Vaccines; Immunogenicity; Measles; Mumps; Rubella; Varicella Vaccine; Combined Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; DNA Virus Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Togaviridae Infections; Rubivirus Infections; Measles; Herpes Zoster; Chickenpox; Rubella; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 110058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Annotated Case Report Form
   Information identifier: 110058
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 110058
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: 110058
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 110058
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 110058
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: 110058
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Study Protocol
   Information identifier: 110058
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register