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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00578175
Other study ID # 110058
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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®).

Study Design


Related Conditions & MeSH terms


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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