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

NCT ID: NCT00578175

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1851 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-20
• Study Completion Date: 2009-03-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Priorix-Tetra™ (MMRV vaccine 208136)

Intervention Type: BIOLOGICAL

One subcutaneous injection.

Havrix®

Intervention Type: BIOLOGICAL

Two intramuscular injections.

Prevnar®

Intervention Type: BIOLOGICAL

One intramuscular injection.

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

Group Type: EXPERIMENTAL

Priorix-Tetra™ (MMRV vaccine 208136)

Intervention Type: BIOLOGICAL

One subcutaneous injection.

Havrix®

Intervention Type: BIOLOGICAL

Two intramuscular injections.

Prevnar®

Intervention Type: BIOLOGICAL

One intramuscular injection.

Group C

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

Group Type: ACTIVE_COMPARATOR

ProQuad®

Intervention Type: BIOLOGICAL

One subcutaneous injection.

Havrix®

Intervention Type: BIOLOGICAL

Two intramuscular injections.

Prevnar®

Intervention Type: BIOLOGICAL

One intramuscular injection.

Interventions

Priorix-Tetra™ (MMRV vaccine 208136)

One subcutaneous injection.

Intervention Type: BIOLOGICAL

ProQuad®

One subcutaneous injection.

Intervention Type: BIOLOGICAL

Havrix®

Two intramuscular injections.

Intervention Type: BIOLOGICAL

Prevnar®

One intramuscular injection.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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®).

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Benton, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Buena Park, California, United States

GSK Investigational Site

Downey, California, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Fremont, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Hayward, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Lakewood, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Paramount, California, United States

GSK Investigational Site

Pleasanton, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

San Jose, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Vacaville, California, United States

GSK Investigational Site

West Covina, California, United States

GSK Investigational Site

Centennial, Colorado, United States

GSK Investigational Site

Thornton, Colorado, United States

GSK Investigational Site

Westminster, Colorado, United States

GSK Investigational Site

Boynton Beach, Florida, United States

GSK Investigational Site

Opa-locka, Florida, United States

GSK Investigational Site

Plantation, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Carrollton, Georgia, United States

GSK Investigational Site

Dalton, Georgia, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Tifton, Georgia, United States

GSK Investigational Site

Tucker, Georgia, United States

GSK Investigational Site

Woodstock, Georgia, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Nampa, Idaho, United States

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DeKalb, Illinois, United States

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Fishers, Indiana, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Lafayette, Indiana, United States

GSK Investigational Site

New Albany, Indiana, United States

GSK Investigational Site

Dubuque, Iowa, United States

GSK Investigational Site

Dubuque, Iowa, United States

GSK Investigational Site

Waukee, Iowa, United States

GSK Investigational Site

West Des Moines, Iowa, United States

GSK Investigational Site

Arkansas City, Kansas, United States

GSK Investigational Site

Overland Park, Kansas, United States

GSK Investigational Site

Topeka, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Owensboro, Kentucky, United States

GSK Investigational Site

Springfield, Kentucky, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Frederick, Maryland, United States

GSK Investigational Site

Fall River, Massachusetts, United States

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Woburn, Massachusetts, United States

GSK Investigational Site

Kalamazoo, Michigan, United States

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Niles, Michigan, United States

GSK Investigational Site

Portage, Michigan, United States

GSK Investigational Site

Richland, Michigan, United States

GSK Investigational Site

Stevensville, Michigan, United States

GSK Investigational Site

Brainerd, Minnesota, United States

GSK Investigational Site

Saint Paul, Minnesota, United States

GSK Investigational Site

Bridgeton, Missouri, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Bellevue, Nebraska, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Whitehouse Station, New Jersey, United States

GSK Investigational Site

Johnson City, New York, United States

GSK Investigational Site

Lake Success, New York, United States

GSK Investigational Site

Mineola, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Stony Brook, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Utica, New York, United States

GSK Investigational Site

Boone, North Carolina, United States

GSK Investigational Site

Cary, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Sylva, North Carolina, United States

GSK Investigational Site

Fargo, North Dakota, United States

GSK Investigational Site

Minot, North Dakota, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Fairfield, Ohio, United States

GSK Investigational Site

Huber Heights, Ohio, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Eugene, Oregon, United States

GSK Investigational Site

Gresham, Oregon, United States

GSK Investigational Site

Altoona, Pennsylvania, United States

GSK Investigational Site

East Norriton, Pennsylvania, United States

GSK Investigational Site

Kittanning, Pennsylvania, United States

GSK Investigational Site

Latrobe, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Sellersville, Pennsylvania, United States

GSK Investigational Site

Uniontown, Pennsylvania, United States

GSK Investigational Site

Wexford, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Brentwood, Tennessee, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Amarillo, Texas, United States

GSK Investigational Site

Bryan, Texas, United States

GSK Investigational Site

Corpus Christi, Texas, United States

GSK Investigational Site

Lubbock, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Sugar Land, Texas, United States

GSK Investigational Site

Layton, Utah, United States

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Ogden, Utah, United States

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Provo, Utah, United States

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South Jordan, Utah, United States

GSK Investigational Site

St. George, Utah, United States

GSK Investigational Site

West Jordan, Utah, United States

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Charlottesville, Virginia, United States

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Charlottesville, Virginia, United States

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Chesapeake, Virginia, United States

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Midlothian, Virginia, United States

GSK Investigational Site

Vienna, Virginia, United States

GSK Investigational Site

Virginia Beach, Virginia, United States

GSK Investigational Site

Huntington, West Virginia, United States

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La Crosse, Wisconsin, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22622699 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

110058

Identifier Type: -

Identifier Source: org_study_id