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

Measles Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578175
• Other study ID #: 110058
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2007
• Est. completion date: March 17, 2009

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1851
• Est. completion date: March 17, 2009
• Est. primary completion date: February 24, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 14 Months

Eligibility

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®).

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• Priorix-Tetra™ (MMRV vaccine 208136)
One subcutaneous injection.
• ProQuad®
One subcutaneous injection.
• Havrix®
Two intramuscular injections.
• Prevnar®
One intramuscular injection.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Altoona	Pennsylvania
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Arkansas City	Kansas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bardstown	Kentucky
United States	GSK Investigational Site	Bellevue	Nebraska
United States	GSK Investigational Site	Benton	Arkansas
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boone	North Carolina
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Brainerd	Minnesota
United States	GSK Investigational Site	Brentwood	Tennessee
United States	GSK Investigational Site	Bridgeton	Missouri
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Bryan	Texas
United States	GSK Investigational Site	Buena Park	California
United States	GSK Investigational Site	Carrollton	Georgia
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Centennial	Colorado
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chesapeake	Virginia
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Dalton	Georgia
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	DeKalb	Illinois
United States	GSK Investigational Site	Downey	California
United States	GSK Investigational Site	Dubuque	Iowa
United States	GSK Investigational Site	Dubuque	Iowa
United States	GSK Investigational Site	East Norriton	Pennsylvania
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Fairfield	Ohio
United States	GSK Investigational Site	Fall River	Massachusetts
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fishers	Indiana
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Frederick	Maryland
United States	GSK Investigational Site	Fremont	California
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gresham	Oregon
United States	GSK Investigational Site	Hayward	California
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Huber Heights	Ohio
United States	GSK Investigational Site	Huntington	West Virginia
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Johnson City	New York
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	Kittanning	Pennsylvania
United States	GSK Investigational Site	La Crosse	Wisconsin
United States	GSK Investigational Site	Lafayette	Indiana
United States	GSK Investigational Site	Lake Success	New York
United States	GSK Investigational Site	Lakewood	California
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Latrobe	Pennsylvania
United States	GSK Investigational Site	Layton	Utah
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
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	Lubbock	Texas
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Marshfield	Wisconsin
United States	GSK Investigational Site	Midlothian	Virginia
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Minot	North Dakota
United States	GSK Investigational Site	Nampa	Idaho
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Albany	Indiana
United States	GSK Investigational Site	Niles	Michigan
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Opa-locka	Florida
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Phoenix	Arizona
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	Plantation	Florida
United States	GSK Investigational Site	Pleasanton	California
United States	GSK Investigational Site	Portage	Michigan
United States	GSK Investigational Site	Provo	Utah
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Richland	Michigan
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Saint George	Utah
United States	GSK Investigational Site	Saint Paul	Minnesota
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	San Francisco	California
United States	GSK Investigational Site	San Jose	California
United States	GSK Investigational Site	Sellersville	Pennsylvania
United States	GSK Investigational Site	South Jordan	Utah
United States	GSK Investigational Site	Springfield	Kentucky
United States	GSK Investigational Site	Stevensville	Michigan
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Sylva	North Carolina
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Thornton	Colorado
United States	GSK Investigational Site	Tifton	Georgia
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Tucker	Georgia
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Tuscaloosa	Alabama
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Utica	New York
United States	GSK Investigational Site	Vacaville	California
United States	GSK Investigational Site	Vienna	Virginia
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Waukee	Iowa
United States	GSK Investigational Site	West Covina	California
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Westminster	Colorado
United States	GSK Investigational Site	Wexford	Pennsylvania
United States	GSK Investigational Site	White House Station	New Jersey
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Woburn	Massachusetts
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Concentration of Antibodies to Varicella Virus (VZV)	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Primary	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
Primary	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
Primary	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
Primary	Concentration of Antibodies to Hepatitis A Virus (HAV)	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Primary	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	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
Secondary	Concentration of Antibodies to Measles Virus	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Secondary	Concentration of Antibodies to Rubella Virus	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash		During the 43-day follow-up period after vaccination
Secondary	Number of Subjects Reporting Investigator-confirmed Varicella-like Rash		During the 43-day follow-up period after vaccination
Secondary	Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling		During the 43-day follow-up period after vaccination
Secondary	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
Secondary	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)
Secondary	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)

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