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

NCT00578175 | Completed Phase 2 Results

• 1 other identifier: 110058
• Study Type: interventional
• Target: 1,851
• Locations: 1 country
• Sites: 141

Brief Summary

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.

Conditions

Varicella; Rubella; Mumps; Measles

Keywords

Vaccines; Rubella; Varicella Vaccine; Children; Humans; Mumps; Immunogenicity; Safety; Measles; Combined Vaccine

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (17)

• Antibody Titers to Mumps Virus

  At Day 42 after vaccination

• Concentration of Antibodies to Measles Virus

  At Day 42 after vaccination

• Concentration of Antibodies to Rubella Virus

  At Day 42 after vaccination

• Number of Subjects With Vaccine Response to Havrix

  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

  At Day 42 after vaccination

Study Arms (3)

Group A

EXPERIMENTAL

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); Biological: Havrix®; Biological: Prevnar®

Group B

EXPERIMENTAL

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); Biological: Havrix®; Biological: Prevnar®

Group C

ACTIVE COMPARATOR

Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180

Biological: ProQuad®; Biological: Havrix®; Biological: Prevnar®

Interventions

Priorix-Tetra™ (MMRV vaccine 208136) BIOLOGICAL

One subcutaneous injection.

Group A; Group B

ProQuad® BIOLOGICAL

One subcutaneous injection.

Group C

Havrix® BIOLOGICAL

Two intramuscular injections.

Group A; Group B; Group C

Prevnar® BIOLOGICAL

One intramuscular injection.

Group A; Group B; Group C

Eligibility Criteria

• Age: 12 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (141)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

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GSK Investigational Site

Birmingham, Alabama, 35244, United States

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GSK Investigational Site

Tuscaloosa, Alabama, 35401, United States

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Phoenix, Arizona, 85003, United States

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Benton, Arkansas, 72015, United States

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GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

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GSK Investigational Site

Little Rock, Arkansas, 72205, United States

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GSK Investigational Site

Anaheim, California, 92804, United States

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GSK Investigational Site

Anaheim, California, 92805, United States

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GSK Investigational Site

Buena Park, California, 90620, United States

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GSK Investigational Site

Downey, California, 90241, United States

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GSK Investigational Site

Fountain Valley, California, 92708, United States

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GSK Investigational Site

Fremont, California, 94538, United States

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GSK Investigational Site

Fresno, California, 93720, United States

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GSK Investigational Site

Hayward, California, 94545, United States

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GSK Investigational Site

Huntington Beach, California, 92647, United States

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GSK Investigational Site

Lakewood, California, 90711, United States

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GSK Investigational Site

Oakland, California, 94611, United States

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GSK Investigational Site

Paramount, California, 90723, United States

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GSK Investigational Site

Pleasanton, California, 94588, United States

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GSK Investigational Site

San Francisco, California, 94115, United States

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GSK Investigational Site

San Jose, California, 95119, United States

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GSK Investigational Site

Torrance, California, 90502, United States

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GSK Investigational Site

Vacaville, California, 95688, United States

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GSK Investigational Site

West Covina, California, 91790, United States

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GSK Investigational Site

Centennial, Colorado, 80112, United States

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GSK Investigational Site

Thornton, Colorado, 80233, United States

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GSK Investigational Site

Westminster, Colorado, 80234, United States

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Boynton Beach, Florida, 33437, United States

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GSK Investigational Site

Opa-locka, Florida, 33054, United States

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GSK Investigational Site

Plantation, Florida, 33324, United States

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GSK Investigational Site

West Palm Beach, Florida, 33407, United States

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GSK Investigational Site

Carrollton, Georgia, 30117, United States

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GSK Investigational Site

Dalton, Georgia, 30721, United States

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GSK Investigational Site

Marietta, Georgia, 30062, United States

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GSK Investigational Site

Tifton, Georgia, 31794, United States

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GSK Investigational Site

Tucker, Georgia, 30084, United States

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Woodstock, Georgia, 30189, United States

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Honolulu, Hawaii, 96814, United States

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Honolulu, Hawaii, 96819, United States

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Nampa, Idaho, 208 463 3126, United States

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DeKalb, Illinois, 60115, United States

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Fishers, Indiana, 46038, United States

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Indianapolis, Indiana, 46229, United States

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Lafayette, Indiana, 47904, United States

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GSK Investigational Site

New Albany, Indiana, 47150, United States

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GSK Investigational Site

Dubuque, Iowa, 52001, United States

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GSK Investigational Site

Dubuque, Iowa, 52002, United States

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GSK Investigational Site

Waukee, Iowa, 50263, United States

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GSK Investigational Site

West Des Moines, Iowa, 50266, United States

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GSK Investigational Site

Arkansas City, Kansas, 67005, United States

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GSK Investigational Site

Overland Park, Kansas, 66215, United States

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Topeka, Kansas, 66608, United States

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Wichita, Kansas, 67208, United States

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Bardstown, Kentucky, 40004, United States

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GSK Investigational Site

Lexington, Kentucky, 40503, United States

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GSK Investigational Site

Louisville, Kentucky, 40202, United States

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GSK Investigational Site

Louisville, Kentucky, 40272, United States

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GSK Investigational Site

Louisville, Kentucky, 40291, United States

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Owensboro, Kentucky, 43202, United States

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GSK Investigational Site

Springfield, Kentucky, 40069, United States

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GSK Investigational Site

Baltimore, Maryland, 21201, United States

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GSK Investigational Site

Frederick, Maryland, 21702, United States

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Fall River, Massachusetts, 02724, United States

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Woburn, Massachusetts, 01801, United States

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Kalamazoo, Michigan, 49008, United States

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Niles, Michigan, 49120, United States

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Portage, Michigan, 49024, United States

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Richland, Michigan, 49083, United States

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Stevensville, Michigan, 49127, United States

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Brainerd, Minnesota, 56401, United States

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Saint Paul, Minnesota, 55108, United States

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Bridgeton, Missouri, 63044, United States

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Columbia, Missouri, 65203, United States

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GSK Investigational Site

Kansas City, Missouri, 64108, United States

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Bellevue, Nebraska, 68123, United States

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GSK Investigational Site

Omaha, Nebraska, 68131, United States

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GSK Investigational Site

Omaha, Nebraska, 68132, United States

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GSK Investigational Site

Henderson, Nevada, 89015, United States

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GSK Investigational Site

Las Vegas, Nevada, 89101, United States

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GSK Investigational Site

Whitehouse Station, New Jersey, 08889, United States

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GSK Investigational Site

Johnson City, New York, 13790, United States

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GSK Investigational Site

Lake Success, New York, 11040, United States

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GSK Investigational Site

Mineola, New York, 11501, United States

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GSK Investigational Site

Rochester, New York, 14618, United States

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GSK Investigational Site

Stony Brook, New York, 11794, United States

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GSK Investigational Site

Syracuse, New York, 13205, United States

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GSK Investigational Site

Utica, New York, 13502, United States

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GSK Investigational Site

Boone, North Carolina, 28607, United States

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GSK Investigational Site

Cary, North Carolina, 27518, United States

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Raleigh, North Carolina, 27609, United States

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Sylva, North Carolina, 28779, United States

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Fargo, North Dakota, 58103, United States

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Minot, North Dakota, 58701, United States

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Cincinnati, Ohio, 45245, United States

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Dayton, Ohio, 45406, United States

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Fairfield, Ohio, 45014, United States

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Huber Heights, Ohio, 45424, United States

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Tulsa, Oklahoma, 74107, United States

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Eugene, Oregon, 97402, United States

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GSK Investigational Site

Gresham, Oregon, 97030, United States

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Altoona, Pennsylvania, 16602, United States

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East Norriton, Pennsylvania, 19401, United States

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Kittanning, Pennsylvania, 16201, United States

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GSK Investigational Site

Latrobe, Pennsylvania, 15650, United States

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Pittsburgh, Pennsylvania, 15213, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15217, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15236, United States

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GSK Investigational Site

Sellersville, Pennsylvania, 18960, United States

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GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

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GSK Investigational Site

Wexford, Pennsylvania, 15090, United States

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GSK Investigational Site

Charleston, South Carolina, 29406, United States

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GSK Investigational Site

Brentwood, Tennessee, 37027, United States

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GSK Investigational Site

Bristol, Tennessee, 37620, United States

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Kingsport, Tennessee, 37660, United States

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GSK Investigational Site

Nashville, Tennessee, 37203, United States

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GSK Investigational Site

Amarillo, Texas, 79124, United States

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GSK Investigational Site

Bryan, Texas, 77802, United States

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GSK Investigational Site

Corpus Christi, Texas, 78411, United States

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GSK Investigational Site

Lubbock, Texas, 79430, United States

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GSK Investigational Site

San Antonio, Texas, 78205, United States

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GSK Investigational Site

San Antonio, Texas, 78212, United States

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GSK Investigational Site

San Antonio, Texas, 78215, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Sugar Land, Texas, 77479, United States

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GSK Investigational Site

Layton, Utah, 84041, United States

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GSK Investigational Site

Ogden, Utah, 84405, United States

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GSK Investigational Site

Provo, Utah, 84604, United States

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GSK Investigational Site

South Jordan, Utah, 84095, United States

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GSK Investigational Site

St. George, Utah, 84790, United States

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GSK Investigational Site

West Jordan, Utah, 84088, United States

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GSK Investigational Site

Charlottesville, Virginia, 22902, United States

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GSK Investigational Site

Charlottesville, Virginia, 22903, United States

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GSK Investigational Site

Chesapeake, Virginia, 23321, United States

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GSK Investigational Site

Midlothian, Virginia, 23113, United States

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GSK Investigational Site

Vienna, Virginia, 22180, United States

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GSK Investigational Site

Virginia Beach, Virginia, 23454, United States

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GSK Investigational Site

Huntington, West Virginia, 25701, United States

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GSK Investigational Site

La Crosse, Wisconsin, 54601, United States

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GSK Investigational Site

Madison, Wisconsin, 53792, United States

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GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

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Related Publications (1)

• 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.

  PMID: 22622699 BACKGROUND

Related 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.

MeSH Terms

Conditions

Chickenpox; Rubella; Mumps; Measles

Interventions

measles, mumps, rubella, varicella vaccine; Hepatitis A Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Rubivirus Infections; Togaviridae Infections; RNA Virus Infections; Rubulavirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Morbillivirus Infections

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines, Combined

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 21, 2007
• Study Start: November 20, 2007
• Primary Completion: February 24, 2009
• Study Completion: March 17, 2009
• Last Updated: October 9, 2018
• Results First Posted: August 26, 2010

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (141)